Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients with Germ Cell Tumors

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Status: Active

Description

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Eligibility Criteria

Inclusion Criteria

  • Low risk stratum (stage I ovarian immature teratoma and stage I malignant GCT [all sites]): Patients must be < 50 years of age at enrollment
  • Standard risk 1: Patient must be < 11 years of age at enrollment
  • Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment
  • Newly diagnosed patients must have histologic verification of a primary extracranial germ cell tumor in any of the categories outlined; elevation of serum tumor markers without histologic confirmation is not sufficient for entry on the trial * NOTE: for low risk patients, materials for rapid surgical central review must be sent within 7 days of study enrollment
  • Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma, mixed immature and mature teratoma, (no pathological evidence of mediastinal germ cell tumor [MGCT]); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; age (years) < 50
  • Low risk stage I MCGT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA and IB; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); age (years) < 50
  • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); age (years) < 11
  • Standard risk 2 (SR2) * Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); age (years) >= 11 and < 25 * Site: testicular; stage: COG stage II-IV, AJCC stage II, III, International Germ Cell Consensus Classification (IGCCC) good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); tumor markers: for IGCCC good risk: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 1.5 x normal; age (years) >= 11 and < 25 * Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed) age (years) >= 11 and < 25
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2
  • A serum creatinine based on age/gender as follows: (mg/dL) * 1 month to < 6 months male: 0.4 female: 0.4 * 6 months to < 1 year male: 0.5 female: 0.5 * 1 to < 2 years male: 0.6 female: 0.6 * 2 to < 6 years male: 0.8 female: 0.8 * 6 to < 10 years male: 1 female: 1 * 10 to < 13 years male: 1.2 female: 1.2 * 13 to < 16 years: male: 1.5 female: 1.4 * >= 16 years male: 1.7 female: 1.4
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L)
  • No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication or determination; pulmonary function tests (PFTs) are not required
  • Eligibility criteria to participate in group 1 of the pilot study of the AYA-Hears instrument Note: participants in group 1 will not receive protocol-directed therapy
  • >= 11 and < 25 years old at enrollment
  • Able to fluently speak and read English
  • Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
  • Followed for cancer or survivorship care at one of the following institutions: * Dana Farber/Harvard Cancer Center * Hospital for Sick Children * Children’s Hospital of Eastern Ontario * Oregon Health and Science University * Seattle Children’s Hospital * Yale University
  • Has experienced prior or ongoing hearing impairment due to chemotherapy or radiotherapy as defined by one of the following: * Society of Pediatric Oncology (SIOP) grade 1 hearing loss * Subjective (patient-reported) hearing difficulties * Subjective (patient-reported) tinnitus

Exclusion Criteria

  • Patients with any diagnoses not listed including: * Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection) * Pure dysgerminoma and pure seminoma * Pure mature teratoma * Pure immature teratoma COG stage I with alpha-fetoprotein (AFP) >= 1000 ng/mL * Pure immature teratoma COG stage II - IV or FIGO stage IC to IV * Poor risk disease (age >= 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular), or * Primary central nervous system (CNS) germ cell tumor
  • Patients must have had no prior systemic therapy
  • Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial)
  • SR1 and SR2 patients:
  • Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
  • Lactating females who plan to breastfeed their infants
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation

Locations & Contacts

Alabama

Mobile
University of South Alabama
Status: Active
Contact: Felicia Little Wilson
Phone: 251-665-8000

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Oncology and Hematology LLC
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Women's Cancer Care
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 888-823-5923 Email: ctsucontact@westat.com
Anchorage Associates in Radiation Medicine
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Oncology Centre
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org
Katmai Oncology Group
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org
Providence Alaska Medical Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 907-212-6871 Email: AKPAMC.OncologyResearchSupport@providence.org

Arizona

Mesa
Cardon Children's Medical Center
Status: Active
Contact: Erlyn C. Smith Email: helpdesk@childrensoncologygroup.org

Arkansas

Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Little Rock
Arkansas Children's Hospital
Status: Active
Contact: David L. Becton Email: helpdesk@childrensoncologygroup.org
University of Arkansas for Medical Sciences
Status: Active
Contact: Kristin Kelley Zorn
Phone: 501-686-8274

California

Anaheim
Kaiser Permanente-Anaheim
Status: Active
Contact: Robert Michael Cooper
Phone: 626-564-3455
Arroyo Grande
PCR Oncology
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Bellflower
Kaiser Permanente-Bellflower
Status: Active
Contact: Robert Michael Cooper
Phone: 626-564-3455
Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 818-708-5550 Email: Monica.Palacios@providence.org
Downey
Kaiser Permanente Downey Medical Center
Status: Active
Contact: Robert Michael Cooper
Phone: 626-564-3455
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Anna Beata Pawlowska
Phone: 800-826-4673 Email: becomingapatient@coh.org
Fontana
Kaiser Permanente-Fontana
Status: Active
Contact: Robert Michael Cooper
Phone: 626-564-3455
Loma Linda
Loma Linda University Medical Center
Status: Active
Contact: Albert Kheradpour
Phone: 909-558-3375
Long Beach
Miller Children's and Women's Hospital Long Beach
Status: Active
Contact: Pamela Helen-Heilge Kempert Email: helpdesk@childrensoncologygroup.org
Los Angeles
Children's Hospital Los Angeles
Status: Active
Contact: Leo Mascarenhas Email: helpdesk@childrensoncologygroup.org
Kaiser Permanente Los Angeles Medical Center
Status: Active
Contact: Robert Michael Cooper
Phone: 626-564-3455
Madera
Children's Hospital Central California
Status: Active
Contact: Vonda Lee Crouse Email: helpdesk@childrensoncologygroup.org
Oakland
Children's Hospital and Research Center at Oakland
Status: Active
Contact: Carla Barbara Golden Email: helpdesk@childrensoncologygroup.org
Orange
Children's Hospital of Orange County
Status: Active
Contact: Elyssa M. Rubin Email: helpdesk@childrensoncologygroup.org
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: Active
Contact: Sheri L Spunt Email: helpdesk@childrensoncologygroup.org
Stanford Cancer Institute Palo Alto
Status: Active
Contact: Sheri L Spunt
Phone: 650-498-7061 Email: ccto-office@stanford.edu
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Marcio Henrique Malogolowkin
Phone: 916-734-3089
San Diego
Kaiser Permanente-San Diego Mission
Status: Active
Contact: Robert Michael Cooper
Phone: 626-564-3455
Naval Medical Center -San Diego
Status: Active
Contact: Shelton August Viola
Phone: 619-532-8712
Rady Children's Hospital - San Diego
Status: Active
Contact: William D. Roberts Email: helpdesk@childrensoncologygroup.org
Torrance
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Status: Active
Contact: Eduard H. Panosyan
Phone: 310-222-3621

Colorado

Aurora
Children's Hospital Colorado
Status: Active
Contact: Timothy Price Garrington Email: helpdesk@childrensoncologygroup.org
University of Colorado Hospital
Status: Active
Contact: Brandon David Bernard
Phone: 720-848-0650
Colorado Springs
Memorial Hospital North
Status: Active
Contact: Brandon David Bernard
Phone: 719-364-6700
Penrose-Saint Francis Healthcare
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Rocky Mountain Cancer Centers-Penrose
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
UCHealth Memorial Hospital Central
Status: Active
Contact: Brandon David Bernard
Phone: 719-365-2406
Denver
Porter Adventist Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: Active
Contact: Jennifer Jocelyn Clark Email: helpdesk@childrensoncologygroup.org
Durango
Mercy Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Southwest Oncology PC
Status: Temporarily closed to accrual
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Fort Collins
Cancer Care and Hematology-Fort Collins
Status: Active
Contact: Timothy Price Garrington
Phone: 888-823-5923 Email: ctsucontact@westat.com
Poudre Valley Hospital
Status: Active
Contact: Brandon David Bernard
Phone: 970-297-6150
Golden
Mountain Blue Cancer Care Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Greeley
UCHealth Greeley Hospital
Status: Active
Contact: Timothy Price Garrington
Phone: 888-823-5923 Email: ctsucontact@westat.com
Lakewood
Rocky Mountain Cancer Centers-Lakewood
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Saint Anthony Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Littleton
Littleton Adventist Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Lone Tree
UCHealth Lone Tree Health Center
Status: Active
Contact: Brandon David Bernard
Phone: 888-823-5923 Email: ctsucontact@westat.com
Longmont
Longmont United Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Rocky Mountain Cancer Centers-Longmont
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Loveland
Medical Center of the Rockies
Status: Active
Contact: Brandon David Bernard
Phone: 970-203-7083
Parker
Parker Adventist Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Rocky Mountain Cancer Centers-Parker
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Pueblo
Rocky Mountain Cancer Centers - Pueblo
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Saint Mary Corwin Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org
Thornton
Rocky Mountain Cancer Centers-Thornton
Status: Active
Contact: Mehmet Sitki Copur
Phone: 303-777-2663 Email: kgeisen@co-cancerresearch.org

Connecticut

Hartford
Connecticut Children's Medical Center
Status: Active
Contact: Michael Scott Isakoff Email: helpdesk@childrensoncologygroup.org
New Haven
Yale University
Status: Active
Contact: Nina Singh Kadan-Lottick
Phone: 203-785-5702

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: Active
Contact: Ramamoorthy Nagasubramanian
Phone: 302-651-5755

District of Columbia

Washington
Children's National Medical Center
Status: Active
Contact: Jeffrey Stuart Dome Email: helpdesk@childrensoncologygroup.org
Kaiser Permanente-Capitol Hill Medical Center
Status: Active
Contact: Jeffrey Stuart Dome
Phone: 301-548-5743

Florida

Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: Active
Contact: Emad K. Salman Email: helpdesk@childrensoncologygroup.org
Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Contact: William Birdsall Slayton Email: helpdesk@childrensoncologygroup.org
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: Active
Contact: Iftikhar Hanif Email: helpdesk@childrensoncologygroup.org
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: Active
Contact: Ramamoorthy Nagasubramanian Email: helpdesk@childrensoncologygroup.org
Miami
Nicklaus Children's Hospital
Status: Active
Contact: Enrique Alberto Escalon Email: helpdesk@childrensoncologygroup.org
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Contact: Julio Cesar Barredo
Phone: 305-243-2647
Orlando
Arnold Palmer Hospital for Children
Status: Active
Contact: Vincent Ferdinando Giusti
Phone: 321-843-2584 Email: melissa.leffin@orlandohealth.com
Florida Hospital Orlando
Status: Active
Contact: Fouad M. Hajjar
Phone: 407-303-2090 Email: FH.Cancer.Research@flhosp.org
Nemours Children's Hospital
Status: Active
Contact: Ramamoorthy Nagasubramanian Email: helpdesk@childrensoncologygroup.org
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: Active
Contact: Jennifer Lynne Root Mayer Email: helpdesk@childrensoncologygroup.org
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: Active
Contact: Mark J. Mogul
Phone: 704-384-5369
Tampa General Hospital
Status: Active
Contact: Juan Felipe Rico
Phone: 813-844-8113 Email: hkourtellis@tgh.org
West Palm Beach
Saint Mary's Hospital
Status: Active
Contact: Narayana Gowda Email: helpdesk@childrensoncologygroup.org

Hawaii

Honolulu
Kaiser Permanente Moanalua Medical Center
Status: Active
Contact: Wade T. Kyono
Phone: 808-432-5195
Kapiolani Medical Center for Women and Children
Status: Active
Contact: Wade T. Kyono
Phone: 808-983-6090
Straub Clinic and Hospital
Status: Active
Contact: Wade T. Kyono
Phone: 808-522-4333

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Benjamin Buckner Bridges Email: helpdesk@childrensoncologygroup.org
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 888-823-5923 Email: ctsucontact@westat.com
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 888-823-5923 Email: ctsucontact@westat.com
Nampa
Saint Luke's Mountain States Tumor Institute - Nampa
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 888-823-5923 Email: ctsucontact@westat.com
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 888-823-5923 Email: ctsucontact@westat.com

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Carbondale
Memorial Hospital of Carbondale
Status: Active
Contact: Bryan A. Faller
Phone: 618-457-5200 Email: clinical.research@sih.net
Carterville
SIH Cancer Institute
Status: Active
Contact: Bryan A. Faller
Phone: 618-985-3333 Email: clinical.research@sih.net
Carthage
Illinois CancerCare-Carthage
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Centralia
Centralia Oncology Clinic
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Chicago
John H Stroger Jr Hospital of Cook County
Status: Active
Contact: Mary Lou Schmidt
Phone: 312-864-6000
Lurie Children's Hospital-Chicago
Status: Active
Contact: Jennifer L. Reichek Email: helpdesk@childrensoncologygroup.org
Rush University Medical Center
Status: Active
Contact: Mary Lou Schmidt
Phone: 312-942-5498 Email: clinical_trials@rush.edu
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Susan Lerner Cohn
Phone: 773-834-7424
University of Illinois
Status: Active
Contact: Mary Lou Schmidt
Phone: 312-355-3046
Decatur
Cancer Care Specialists of Central Illinois
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Decatur Memorial Hospital
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Effingham
Crossroads Cancer Center
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Eureka
Illinois CancerCare-Eureka
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: Active
Contact: Jean A. Hurteau
Phone: 847-570-2109
Galesburg
Illinois CancerCare-Galesburg
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Western Illinois Cancer Treatment Center
Status: Active
Contact: Bryan A. Faller
Phone: 309-344-2831
Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Status: Active
Contact: Jean A. Hurteau
Phone: 847-570-2109
Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Status: Active
Contact: Jean A. Hurteau
Phone: 847-570-2109
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: Active
Contact: Caroline Yingwen Hu Email: helpdesk@childrensoncologygroup.org
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Methodist Medical Center of Illinois
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
OSF Saint Francis Medical Center
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Saint Jude Midwest Affiliate
Status: Active
Contact: Pedro A. De Alarcon
Phone: 888-226-4343
Peru
Illinois CancerCare-Peru
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Valley Radiation Oncology
Status: Active
Contact: Bryan A. Faller
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: Active
Contact: Bryan A. Faller
Phone: 309-243-3605 Email: andersonj@illinoiscancercare.com
Skokie
North Shore Medical Center
Status: Active
Contact: Jean A. Hurteau
Phone: 888-823-5923 Email: ctsucontact@westat.com
Springfield
Memorial Medical Center
Status: Active
Contact: Gregory P. Brandt
Phone: 217-788-4233
Saint John's Hospital
Status: Active
Contact: Gregory P. Brandt
Phone: 888-823-5923 Email: ctsucontact@westat.com
Southern Illinois University School of Medicine
Status: Active
Contact: Gregory P. Brandt
Phone: 217-545-7929
Springfield Clinic
Status: Active
Contact: Bryan A. Faller
Phone: 800-444-7541
Swansea
Cancer Care Specialists of Illinois-Swansea
Status: Active
Contact: Bryan A. Faller
Phone: 217-876-4740 Email: rhamrick@dmhhs.org
Memorial and Saint Elizabeth's Health Care Services LLP
Status: Active
Contact: Bryan A. Faller
Phone: 888-823-5923 Email: ctsucontact@westat.com

Indiana

Carmel
IU Health North Hospital
Status: Active
Contact: Kamnesh Ratnakar Pradhan
Phone: 317-278-2176
Indianapolis
Riley Hospital for Children
Status: Active
Contact: Kamnesh Ratnakar Pradhan
Phone: 800-248-1199
Saint Vincent Hospital and Health Care Center
Status: Active
Contact: Bassem I. Razzouk
Phone: 317-338-2194 Email: research@stvincent.org
South Bend
Memorial Hospital of South Bend
Status: Active
Contact: Kamnesh Ratnakar Pradhan
Phone: 800-284-7370

Iowa

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: Active
Contact: Mehmet Sitki Copur
Phone: 515-247-3970
Mercy Cancer Center-West Lakes
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com
Council Bluffs
Alegent Health Mercy Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com
Creston
Greater Regional Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 641-782-3693 Email: KOllinger@mercydesmoines.org
Des Moines
Blank Children's Hospital
Status: Active
Contact: Wendy Leigh Woods-Swafford Email: helpdesk@childrensoncologygroup.org
Iowa Lutheran Hospital
Status: Active
Contact: Wendy Leigh Woods-Swafford
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: Active
Contact: Wendy Leigh Woods-Swafford
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Laurel
Status: Active
Contact: Mehmet Sitki Copur
Phone: 515-247-3970
Mercy Medical Center - Des Moines
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-221-4849
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Mariko Sato
Phone: 800-237-1225
West Des Moines
Mercy Medical Center-West Lakes
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com

Kentucky

Bardstown
Flaget Memorial Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 502-350-5700
Corbin
Commonwealth Cancer Center-Corbin
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com
Lexington
Saint Joseph Hospital East
Status: Active
Contact: Mehmet Sitki Copur
Phone: 859-967-5107
Saint Joseph Radiation Oncology Resource Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 859-277-3737 Email: hollinaw@sjhlex.org
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Lars Martin Wagner
Phone: 859-257-3379
London
Saint Joseph London
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com
Louisville
Jewish Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 502-587-4103
Jewish Hospital Medical Center Northeast
Status: Active
Contact: Mehmet Sitki Copur
Phone: 502-210-4200
Norton Children's Hospital
Status: Active
Contact: Ashok B. Raj Email: helpdesk@childrensoncologygroup.org
Saints Mary and Elizabeth Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 502-587-4108
Shepherdsville
Jewish Hospital Medical Center South
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: Active
Contact: Craig Lotterman
Phone: 504-842-3708

Maine

Bangor
Eastern Maine Medical Center
Status: Active
Contact: Nadine Patricia Sauer SantaCruz
Phone: 207-973-4274
Brewer
Lafayette Family Cancer Center-EMMC
Status: Active
Contact: Nadine Patricia Sauer SantaCruz
Phone: 800-987-3005

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Alan David Friedman
Phone: 410-955-8804 Email: jhcccro@jhmi.edu
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Teresa Anne York
Phone: 800-888-8823

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Active
Contact: A. Lindsay Frazier
Phone: 877-442-3324
Massachusetts General Hospital Cancer Center
Status: Active
Contact: A. Lindsay Frazier
Phone: 877-726-5130
Worcester
University of Massachusetts Medical School
Status: Active
Contact: Christopher P. Keuker
Phone: 508-856-3216 Email: cancer.research@umassmed.edu

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: Active
Contact: Rama Jasty Email: helpdesk@childrensoncologygroup.org
Battle Creek
Bronson Battle Creek
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Escanaba
Green Bay Oncology - Escanaba
Status: Active
Contact: Catherine A. Long
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: Active
Contact: Kathleen J. Yost Email: helpdesk@childrensoncologygroup.org
Mercy Health Saint Mary's
Status: Active
Contact: Kathleen J. Yost
Phone: 888-823-5923 Email: ctsucontact@westat.com
Spectrum Health at Butterworth Campus
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Kalamazoo
Borgess Medical Center
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Bronson Methodist Hospital
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
West Michigan Cancer Center
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Muskegon
Mercy Health Mercy Campus
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Niles
Lakeland Hospital Niles
Status: Active
Name Not Available
Phone: 888-823-5923 Email: ctsucontact@westat.com
Port Huron
Lake Huron Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Reed City
Spectrum Health Reed City Hospital
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Royal Oak
Beaumont Children's Hospital-Royal Oak
Status: Active
Contact: Laura Kate Gowans
Phone: 248-551-0360
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Marie Yeager Cancer Center
Status: Temporarily closed to accrual
Name Not Available
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Traverse City
Munson Medical Center
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org
Wyoming
Metro Health Hospital
Status: Active
Contact: Kathleen J. Yost
Phone: 616-391-1230 Email: crcwm-regulatory@crcwm.org

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: Active
Contact: Michael Kerr Richards Email: helpdesk@childrensoncologygroup.org

Mississippi

Jackson
University of Mississippi Medical Center
Status: Active
Contact: Anderson (Andy) Burton Collier
Phone: 601-815-6700

Missouri

Bonne Terre
Parkland Health Center-Bonne Terre
Status: Active
Contact: Bryan A. Faller
Phone: 314-996-5569
Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Bryan A. Faller
Phone: 573-334-2230 Email: sfmc@sfmc.net
Southeast Cancer Center
Status: Active
Contact: Bryan A. Faller
Phone: 573-651-5550
Jefferson City
Capital Region Southwest Campus
Status: Active
Contact: Bryan A. Faller
Phone: 573-632-4814 Email: swooden@mail.crmc.org
Kansas City
The Childrens Mercy Hospital
Status: Active
Contact: Keith Jason August Email: helpdesk@childrensoncologygroup.org
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Bethany Graham Sleckman
Phone: 314-251-6770
Missouri Baptist Medical Center
Status: Active
Contact: Bryan A. Faller
Phone: 314-996-5569
Washington University School of Medicine
Status: Active
Contact: Robert J. Hayashi
Phone: 800-600-3606 Email: info@siteman.wustl.edu
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: Active
Contact: Bryan A. Faller
Phone: 314-996-5569
Sullivan
Missouri Baptist Sullivan Hospital
Status: Active
Contact: Bryan A. Faller
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: Active
Contact: Bryan A. Faller
Phone: 314-996-5569

Montana

Missoula
Saint Patrick Hospital - Community Hospital
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 406-329-7029

Nebraska

Grand Island
CHI Health Saint Francis
Status: Active
Contact: Mehmet Sitki Copur
Phone: 800-998-2119
Kearney
CHI Health Good Samaritan
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com
Heartland Hematology and Oncology
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-865-2303
Lincoln
Saint Elizabeth Regional Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 402-483-2827
Omaha
Alegent Health Bergan Mercy Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 402-398-6060
Alegent Health Immanuel Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 402-343-8511 Email: research@alegent.org
Alegent Health Lakeside Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com
Creighton University Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 402-280-4100
Hematology and Oncology Consultants PC
Status: Active
Contact: Mehmet Sitki Copur
Phone: 402-572-3535
Papillion
Midlands Community Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 800-253-4638

Nevada

Carson City
Carson Tahoe Regional Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Henderson
Cancer and Blood Specialists-Henderson
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Henderson
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Status: Active
Contact: Alan K. Ikeda
Phone: 702-822-2000
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Las Vegas Cancer Center-Henderson
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013 Email: research@sncrf.org
Nevada Cancer Specialists-Saint Rose
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Las Vegas
Ann M Wierman MD LTD
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Cancer and Blood Specialists-Shadow
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Cancer and Blood Specialists-Tenaya
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Cancer Therapy and Integrative Medicine
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Children's Specialty Center of Nevada II
Status: Active
Contact: Alan K. Ikeda Email: helpdesk@childrensoncologygroup.org
Comprehensive Cancer Centers of Nevada
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Central Valley
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Northwest
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Summerlin
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Desert West Surgery
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Hope Cancer Care of Nevada
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Las Vegas Cancer Center-Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013 Email: research@sncrf.org
Nevada Cancer Specialists?Oakey
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Nevada Cancer Specialists-Fort Apache
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Nevada Cancer Specialists-Tenaya
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Central
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Southeast
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
University Cancer Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Women's Cancer Center of Nevada
Status: Active
Contact: Nicola M. Spirtos
Phone: 888-823-5923 Email: ctsucontact@westat.com
Pahrump
Hope Cancer Care of Nevada-Pahrump
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Reno
Alpine Hematology-Oncology
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Radiation Oncology Associates
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Reno Oncology Consultants
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Renown Regional Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 702-384-0013
Saint Mary's Regional Medical Center
Status: Active
Contact: Alan K. Ikeda
Phone: 888-823-5923 Email: ctsucontact@westat.com

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Sara Chaffee
Phone: 800-639-6918 Email: cancer.research.nurse@dartmouth.edu

New Jersey

Hackensack
Hackensack University Medical Center
Status: Active
Contact: Burton Eliot Appel
Phone: 201-996-2879
Morristown
Morristown Medical Center
Status: Active
Contact: Steven Lon Halpern
Phone: 973-971-5900
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: Active
Contact: Archana Sharma
Phone: 732-235-8675
Newark
Newark Beth Israel Medical Center
Status: Active
Contact: Peri Kamalakar
Phone: 973-926-7230

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Clare J. Twist
Phone: 877-275-7724
Glens Falls
Glens Falls Hospital
Status: Active
Contact: Jessica Linda Heath
Phone: 518-926-6700
Mineola
NYU Winthrop Hospital
Status: Active
Contact: Mark E. Weinblatt
Phone: 516-663-3115
New York
Columbia University / Herbert Irving Cancer Center
Status: Active
Contact: Alice Lee
Phone: 212-305-8615
Rochester
University of Rochester
Status: Active
Contact: Jeffrey Robert Andolina
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: Active
Contact: Laura Elaina Hogan
Phone: 800-862-2215
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Philip M. Monteleone
Phone: 315-464-5476

North Carolina

Asheville
Mission Hospital-Memorial Campus
Status: Active
Contact: Douglas James Scothorn
Phone: 828-213-4150
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Stuart Harrison Gold
Phone: 877-668-0683 Email: cancerclinicaltrials@med.unc.edu
Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Joel A. Kaplan
Phone: 704-355-2884
Novant Health Presbyterian Medical Center
Status: Active
Contact: Jessica Amy Fu Bell
Phone: 704-384-5369
Oncology Specialists of Charlotte
Status: Active
Contact: Jessica Amy Fu Bell
Phone: 704-342-9577
Southern Oncology Specialists-Charlotte
Status: Active
Contact: Jessica Amy Fu Bell
Phone: 888-823-5923 Email: ctsucontact@westat.com
Huntersville
Lake Norman Hematology Oncology Specialists-Huntersville
Status: Active
Contact: Jessica Amy Fu Bell
Phone: 888-823-5923 Email: ctsucontact@westat.com
Southern Oncology Specialists-Huntersville
Status: Active
Contact: Jessica Amy Fu Bell
Phone: 888-823-5923 Email: ctsucontact@westat.com
Matthews
Matthews Radiation Oncology Center
Status: Active
Contact: Jessica Amy Fu Bell
Phone: 888-823-5923 Email: ctsucontact@westat.com
Novant Health Cancer Specialists-Matthews
Status: Active
Contact: Jessica Amy Fu Bell
Phone: 888-823-5923 Email: ctsucontact@westat.com
Mooresville
Lake Norman Hematology Oncology Specialists-Mooresville
Status: Active
Contact: Jessica Amy Fu Bell
Phone: 704-799-3946
Salisbury
Carolina Oncology Associates PA
Status: Active
Contact: Jessica Amy Fu Bell
Phone: 704-636-5542
Rowan Regional Medical Center
Status: Active
Contact: Jessica Amy Fu Bell
Phone: 888-823-5923 Email: ctsucontact@westat.com

North Dakota

Fargo
Sanford Broadway Medical Center
Status: Active
Contact: Samuel Odame Anim
Phone: 800-437-4010

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: Active
Contact: Steven J. Kuerbitz Email: helpdesk@childrensoncologygroup.org
Belpre
Strecker Cancer Center-Belpre
Status: Active
Contact: Timothy David Moore
Phone: 800-523-3977 Email: sheree@columbusccop.org
Chillicothe
Adena Regional Medical Center
Status: Active
Contact: Timothy David Moore
Phone: 877-779-7585
Cincinnati
Bethesda North Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 513-862-2230
Cincinnati Children's Hospital Medical Center
Status: Active
Contact: James Ian Geller Email: helpdesk@childrensoncologygroup.org
Good Samaritan Hospital - Cincinnati
Status: Active
Contact: Mehmet Sitki Copur
Phone: 513-862-2230
TriHealth Cancer Institute-Anderson
Status: Active
Contact: Mehmet Sitki Copur
Phone: 513-451-4033
TriHealth Cancer Institute-Westside
Status: Active
Contact: Mehmet Sitki Copur
Phone: 513-451-4033 Email: lisa_wittwer@trihealth.com
Cleveland
Cleveland Clinic Foundation
Status: Active
Contact: Aron Flagg
Phone: 866-223-8100
Columbus
Columbus Oncology and Hematology Associates Inc
Status: Active
Contact: Timothy David Moore
Phone: 888-823-5923 Email: ctsucontact@westat.com
Doctors Hospital
Status: Active
Contact: Timothy David Moore
Phone: 614-566-3275
Grant Medical Center
Status: Active
Contact: Timothy David Moore
Phone: 614-566-4475
Mount Carmel East Hospital
Status: Active
Contact: Timothy David Moore
Phone: 888-823-5923 Email: ctsucontact@westat.com
Mount Carmel Health Center West
Status: Active
Contact: Timothy David Moore
Phone: 614-234-5433
Nationwide Children's Hospital
Status: Active
Contact: Mark Anthony Ranalli Email: helpdesk@childrensoncologygroup.org
Riverside Methodist Hospital
Status: Active
Contact: Timothy David Moore
Phone: 614-566-4475
The Mark H Zangmeister Center
Status: Active
Contact: Timothy David Moore
Phone: 888-823-5923 Email: ctsucontact@westat.com
Dayton
Dayton Children's Hospital
Status: Active
Contact: Ayman Aly El-Sheikh Email: helpdesk@childrensoncologygroup.org
Delaware
Delaware Health Center-Grady Cancer Center
Status: Active
Contact: Timothy David Moore
Phone: 740-615-0227
Grady Memorial Hospital
Status: Active
Contact: Timothy David Moore
Phone: 740-615-2403
Mansfield
OhioHealth Mansfield Hospital
Status: Active
Contact: Timothy David Moore
Phone: 419-526-8018
Marietta
Marietta Memorial Hospital
Status: Active
Contact: Timothy David Moore
Phone: 800-523-3977 Email: sheree@columbusccop.org
Marion
OhioHealth Marion General Hospital
Status: Active
Contact: Timothy David Moore
Phone: 888-823-5923 Email: ctsucontact@westat.com
Mount Vernon
Knox Community Hospital
Status: Active
Contact: Timothy David Moore
Phone: 740-393-9000
Newark
Licking Memorial Hospital
Status: Active
Contact: Timothy David Moore
Phone: 740-348-4000
Portsmouth
Southern Ohio Medical Center
Status: Active
Contact: Timothy David Moore
Phone: 888-823-5923 Email: ctsucontact@westat.com
Sylvania
Flower Hospital
Status: Active
Contact: Jamie L. Dargart
Phone: 419-824-1842
Toledo
The Toledo Hospital / Toledo Children's Hospital
Status: Active
Contact: Jamie L. Dargart
Phone: 419-824-1842
Westerville
Saint Ann's Hospital
Status: Active
Contact: Timothy David Moore
Phone: 888-823-5923 Email: ctsucontact@westat.com
Zanesville
Genesis Healthcare System Cancer Care Center
Status: Active
Contact: Timothy David Moore
Phone: 740-454-5232

Oklahoma

Lawton
Cancer Centers of Southwest Oklahoma Research
Status: Active
Contact: Rene Yvonne McNall-Knapp
Phone: 877-231-4440
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Rene Yvonne McNall-Knapp
Phone: 405-271-8777 Email: ou-clinical-trials@ouhsc.edu

Oregon

Bend
Saint Charles Health System
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 541-647-7786 Email: mboone@stcharleshealthcare.org
Clackamas
Clackamas Radiation Oncology Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Providence Oncology and Hematology Care Southeast
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Coos Bay
Bay Area Hospital
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 541-269-8392 Email: cherie.cox@bayareahospital.org
Medford
Rogue Valley Medical Center
Status: Active
Name Not Available
Phone: 541-789-6176
Newberg
Providence Newberg Medical Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Portland
Legacy Emanuel Children's Hospital
Status: Active
Contact: Janice Faye Olson Email: helpdesk@childrensoncologygroup.org
Oregon Health and Science University
Status: Active
Name Not Available
Phone: 503-494-1080 Email: trials@ohsu.edu
Providence Portland Medical Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 503-215-2614 Email: CanRsrchStudies@providence.org

Pennsylvania

Abington
Abington Memorial Hospital
Status: Active
Contact: Mark Shahram Shahin
Phone: 215-481-2402
Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Active
Contact: Lydia Alberta Boateng
Phone: 734-712-3671
Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: Active
Contact: Lydia Alberta Boateng
Phone: 734-712-3671
Hershey
Penn State Children's Hospital
Status: Active
Contact: Lisa MacNabb McGregor Email: helpdesk@childrensoncologygroup.org
Philadelphia
Children's Hospital of Philadelphia
Status: Active
Contact: Frank M. Balis Email: helpdesk@childrensoncologygroup.org
Childrens Oncology Group
Status: Active
Contact: A. Lindsay Frazier
Phone: 877-442-3324
Saint Christopher's Hospital for Children
Status: Active
Contact: Gregory Emmett Halligan Email: helpdesk@childrensoncologygroup.org
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: Active
Contact: Jean M. Tersak Email: helpdesk@childrensoncologygroup.org

Puerto Rico

Caguas
HIMA San Pablo Oncologic Hospital
Status: Active
Contact: Jhon Alfredo Guerra
Phone: 787-653-3434

Rhode Island

Providence
Rhode Island Hospital
Status: Active
Contact: Jennifer J. Greene Welch
Phone: 401-444-1488

South Carolina

Gaffney
Gibbs Cancer Center-Gaffney
Status: Active
Contact: Michael Humeniuk
Phone: 864-560-6104 Email: kmertz-rivera@gibbscc.org
Greenville
BI-LO Charities Children's Cancer Center
Status: Active
Contact: Nichole Leigh Bryant Email: helpdesk@childrensoncologygroup.org
Saint Francis Cancer Center
Status: Active
Contact: Robert D. Siegel
Phone: 888-823-5923 Email: ctsucontact@westat.com
Saint Francis Hospital
Status: Active
Contact: Robert D. Siegel
Phone: 864-255-1713
Greer
Gibbs Cancer Center-Pelham
Status: Active
Contact: Michael Humeniuk
Phone: 864-560-6104 Email: kmertz-rivera@gibbscc.org
Spartanburg
Spartanburg Medical Center
Status: Active
Contact: Michael Humeniuk
Phone: 864-560-6104 Email: kmertz-rivera@gibbscc.org
Union
MGC Hematology Oncology-Union
Status: Active
Contact: Michael Humeniuk
Phone: 864-560-6104 Email: kmertz-rivera@gibbscc.org

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Kayelyn Jean Wagner
Phone: 605-328-1367

Tennessee

Chattanooga
Memorial Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 423-495-7730
Hixson
Pulmonary Medicine Center of Chattanooga-Hixson
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com
Knoxville
East Tennessee Childrens Hospital
Status: Active
Contact: Ray C. Pais
Phone: 865-541-8266
Memphis
St. Jude Children's Research Hospital
Status: Active
Contact: Alberto S. Pappo Email: helpdesk@childrensoncologygroup.org
Nashville
The Children's Hospital at TriStar Centennial
Status: Active
Contact: Haydar A. Frangoul Email: helpdesk@childrensoncologygroup.org
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Scott C. Borinstein
Phone: 800-811-8480
Ooltewah
Memorial GYN Plus
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: Active
Contact: Amy Catherine Fowler Email: helpdesk@childrensoncologygroup.org
Bryan
Saint Joseph Regional Cancer Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 979-774-0808
Corpus Christi
Driscoll Children's Hospital
Status: Active
Contact: Nkechi Ifeoma Mba Email: helpdesk@childrensoncologygroup.org
Dallas
Medical City Dallas Hospital
Status: Active
Contact: Stanton Carl Goldman
Phone: 972-566-5588
Parkland Memorial Hospital
Status: Active
Contact: Jonathan Eric Wickiser
Phone: 214-590-5582
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Jonathan Eric Wickiser
Phone: 214-648-7097
El Paso
El Paso Children's Hospital
Status: Active
Contact: Lisa Louise Rubin Hartman Email: helpdesk@childrensoncologygroup.org
Texas Tech University Health Sciences Center-El Paso
Status: Active
Contact: Lisa Louise Rubin Hartman
Phone: 888-823-5923 Email: ctsucontact@westat.com
Fort Worth
Cook Children's Medical Center
Status: Active
Contact: Kelly Loren Vallance Email: helpdesk@childrensoncologygroup.org
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Active
Contact: Priya Mahajan
Phone: 713-798-1354 Email: burton@bcm.edu
M D Anderson Cancer Center
Status: Active
Contact: Najat C. Daw
Phone: 713-792-3245
Lubbock
Covenant Children's Hospital
Status: Active
Contact: Kishor Mallikarjun Bhende Email: helpdesk@childrensoncologygroup.org
Texas Tech University Health Sciences Center-Lubbock
Status: Active
Contact: Mohamad M. Al-Rahawan
Phone: 806-775-8590
University Medical Center
Status: Active
Contact: Mohamad M. Al-Rahawan Email: helpdesk@childrensoncologygroup.org
San Antonio
Children's Hospital of San Antonio
Status: Active
Contact: Timothy C. Griffin Email: helpdesk@childrensoncologygroup.org
Methodist Children's Hospital of South Texas
Status: Active
Contact: Vinod Kumar Gidvani-Diaz Email: helpdesk@childrensoncologygroup.org
University Hospital
Status: Active
Contact: Anne-Marie R. Langevin
Phone: 210-358-4176 Email: evelyn.swenson-britt@uhs-sa.com
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Anne-Marie R. Langevin
Phone: 210-450-3800 Email: CTO@uthscsa.edu
Temple
Scott and White Memorial Hospital
Status: Active
Contact: Guy Howard Grayson
Phone: 254-724-5407

Utah

Salt Lake City
Primary Children's Hospital
Status: Active
Contact: Phillip Evan Barnette Email: helpdesk@childrensoncologygroup.org

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: Active
Contact: Jessica Linda Heath
Phone: 802-225-5400
Burlington
University of Vermont College of Medicine
Status: Active
Contact: Jessica Linda Heath
Phone: 802-656-8990
University of Vermont Medical Center
Status: Active
Contact: Jessica Linda Heath
Phone: 802-656-4101

Virginia

Norfolk
Children's Hospital of The King's Daughters
Status: Active
Contact: Eric Jeffrey Lowe Email: helpdesk@childrensoncologygroup.org

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 360-412-8958 Email: deidre.dillon@providence.org
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 360-715-4133 Email: cpatz@peacehealth.org
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Harrison Medical Center
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Burien
Highline Medical Center-Main Campus
Status: Temporarily closed to accrual
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Centralia
Providence Regional Cancer System-Centralia
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 360-412-8958 Email: deidre.dillon@providence.org
Edmonds
Swedish Medical Center-Edmonds
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 206-215-3086 Email: PCRC-NCORP@Swedish.org
Enumclaw
Saint Elizabeth Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com
Everett
Providence Regional Cancer Partnership
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 425-261-3529 Email: marilyn.birchman@providence.org
Federal Way
Saint Francis Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 253-944-8100
Issaquah
Swedish Cancer Institute-Issaquah
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 206-215-3086 Email: PCRC-NCORP@Swedish.org
Kennewick
Kadlec Clinic Hematology and Oncology
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 509-783-4637 Email: research@cbho.org
Lacey
Providence Regional Cancer System-Lacey
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 360-412-8958 Email: deidre.dillon@providence.org
Lakewood
Saint Clare Hospital
Status: Active
Contact: Mehmet Sitki Copur
Phone: 253-985-6110
Longview
PeaceHealth Saint John Medical Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 360-514-2016 Email: bgetman@peacehealth.org
Poulsbo
Harrison HealthPartners Hematology and Oncology-Poulsbo
Status: Active
Contact: Mehmet Sitki Copur
Phone: 308-398-6518 Email: clinicaltrials@sfmc-gi.org
Seattle
Kaiser Permanente Washington
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 206-215-3086 Email: PCRC-NCORP@Swedish.org
Pacific Gynecology Specialists
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 206-215-3086 Email: PCRC-NCORP@Swedish.org
Seattle Children's Hospital
Status: Active
Contact: Douglas S. Hawkins Email: helpdesk@childrensoncologygroup.org
Swedish Medical Center-Ballard Campus
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 206-215-3086 Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Cherry Hill
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 888-823-5923 Email: ctsucontact@westat.com
Swedish Medical Center-First Hill
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 206-215-3086 Email: PCRC-NCORP@Swedish.org
Shelton
Providence Regional Cancer System-Shelton
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 360-412-8958 Email: deidre.dillon@providence.org
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: Active
Contact: Judy L. Felgenhauer Email: helpdesk@childrensoncologygroup.org
Rockwood Cancer Treatment Center-DHEC-Downtown
Status: Temporarily closed to accrual
Contact: Benjamin Buckner Bridges
Phone: 509-724-4454 Email: apope@rockwoodclinic.com
Rockwood North Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Benjamin Buckner Bridges
Phone: 509-724-4454 Email: apope@rockwoodclinic.com
Spokane Valley
Rockwood Clinic Cancer Treatment Center-Valley
Status: Temporarily closed to accrual
Contact: Benjamin Buckner Bridges
Phone: 509-724-4454 Email: apope@rockwoodclinic.com
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Status: Active
Contact: Mehmet Sitki Copur
Phone: 888-823-5923 Email: ctsucontact@westat.com
Madigan Army Medical Center
Status: Active
Contact: Melissa Anne Forouhar
Phone: 253-968-0129 Email: mamcdci@amedd.army.mil
Northwest Medical Specialties PLLC
Status: Active
Contact: Mehmet Sitki Copur
Phone: 253-428-8750
Vancouver
PeaceHealth Southwest Medical Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 360-514-3940 Email: kmakin-bond@peacehealth.org
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 509-897-3320 Email: Cheryl.Dodd@providence.org
Yelm
Providence Regional Cancer System-Yelm
Status: Active
Contact: Benjamin Buckner Bridges
Phone: 360-412-8958 Email: deidre.dillon@providence.org

West Virginia

Bridgeport
United Hospital Center
Status: Active
Contact: Stephan R. Paul
Phone: 304-293-7374 Email: cancertrialsinfo@hsc.wvu.edu
Martinsburg
WVUH-East City Hospital
Status: Active
Contact: Stephan R. Paul
Phone: 304-293-7374 Email: cancertrialsinfo@hsc.wvu.edu
Morgantown
West Virginia University Healthcare
Status: Active
Contact: Stephan R. Paul
Phone: 304-293-7374 Email: cancertrialsinfo@hsc.wvu.edu
Parkersburg
Camden-Clark Memorial Hospital
Status: Active
Contact: Stephan R. Paul
Phone: 304-293-7374 Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Green Bay
Green Bay Oncology at Saint Vincent Hospital
Status: Active
Contact: John Robert Hill
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: Active
Contact: Catherine A. Long
Phone: 888-823-5923 Email: ctsucontact@westat.com
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: Catherine A. Long
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org
Johnson Creek
UW Cancer Center Johnson Creek
Status: Active
Contact: Kenneth Brian De Santes
Phone: 920-699-3500 Email: lynda.persico@uwmf.wisc.edu
Madison
University of Wisconsin Hospital and Clinics
Status: Active
Contact: Kenneth Brian De Santes
Phone: 800-622-8922
Manitowoc
Holy Family Memorial Hospital
Status: Active
Contact: Catherine A. Long
Phone: 920-320-2749
Marinette
Saint Vincent Hospital Cancer Center at Marinette
Status: Active
Contact: Catherine A. Long
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org
Milwaukee
Children's Hospital of Wisconsin
Status: Active
Contact: Meghen B. Browning
Phone: 414-955-4727 Email: MACCCTO@mcw.edu
Oconto Falls
Green Bay Oncology - Oconto Falls
Status: Active
Contact: Catherine A. Long
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org
Sheboygan
HSHS Saint Nicholas Hospital
Status: Active
Contact: Catherine A. Long
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: Active
Contact: Catherine A. Long
Phone: 920-433-8889 Email: Christy.Gilchrist@hshs.org

Alberta

Edmonton
University of Alberta Hospital
Status: Active
Contact: Sarah Jane McKillop
Phone: 780-407-6615 Email: val.taylor@albertahealthservices.ca

Nova Scotia

Halifax
IWK Health Centre
Status: Active
Contact: Conrad Vincent Fernandez
Phone: 902-470-8394

Ontario

Hamilton
McMaster Children's Hospital at Hamilton Health Sciences
Status: Active
Contact: Carol A. Portwine Email: helpdesk@childrensoncologygroup.org
Kingston
Kingston Health Sciences Centre
Status: Active
Contact: Mariana Pradier Silva
Phone: 613-549-6666 Email: cc-clinicaltrials@kgh.kari.net
Ottawa
Children's Hospital of Eastern Ontario
Status: Active
Contact: Donna Lynn Johnston Email: helpdesk@childrensoncologygroup.org

Quebec

Montreal
Centre Hospitalier Universitaire Sainte-Justine
Status: Temporarily closed to accrual
Contact: Yvan Samson
Phone: 514-345-4931
The Montreal Children's Hospital of the MUHC
Status: Active
Contact: Sharon Barbara Abish Email: helpdesk@childrensoncologygroup.org
Quebec
Centre Hospitalier Universitaire de Quebec
Status: Temporarily closed to accrual
Name Not Available Email: helpdesk@childrensoncologygroup.org

Australia

Clayton
Monash Medical Center-Clayton Campus
Status: Active
Contact: Draga Barbaric
Phone: (03) 9928 8111
Hunter Regional Mail Centre
John Hunter Children's Hospital
Status: Active
Contact: Draga Barbaric Email: helpdesk@childrensoncologygroup.org
Parkville
Royal Children's Hospital
Status: Active
Contact: Draga Barbaric Email: helpdesk@childrensoncologygroup.org
Perth
Princess Margaret Hospital for Children
Status: Active
Contact: Marianne Barnetson Phillips
Phone: (08) 9340 8222 Email: catherine.cole@health.wa.gov.au
Randwick
Sydney Children's Hospital
Status: Active
Contact: Draga Barbaric Email: helpdesk@childrensoncologygroup.org
South Brisbane
Lady Cilento Children's Hospital
Status: Active
Contact: Draga Barbaric Email: helpdesk@childrensoncologygroup.org
Westmead
The Children's Hospital at Westmead
Status: Active
Contact: Draga Barbaric Email: helpdesk@childrensoncologygroup.org

New Zealand

Christchurch
Christchurch Hospital
Status: Active
Contact: Tristan Pettit
Phone: 03 364 0640
Grafton
Starship Children's Hospital
Status: Active
Contact: Mark Andrew Winstanley Email: helpdesk@childrensoncologygroup.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients (ages 0- 50 years) with stage I (low risk) malignant germ cell tumors, and at least 98% for patients with ovarian pure immature teratoma.

II. To compare the event-free survival of a carboplatin versus (vs.) cisplatin-based regimen in the treatment of pediatric, adolescent and young adult patients with standard risk germ cell tumors.

III. To compare the event free survival (EFS) of a carboplatin-based regimen (carboplatin [C] etoposide [E] bleomycin [b]) vs. a cisplatin-based regimen (cisplatin [P]Eb) in children (less than 11 years in age) with standard risk germ cell tumors (GCT).

IV. To compare the EFS of a carboplatin-based regimen (BEC) vs. a cisplatin-based regimen (BEP) in adolescents and young adults (ages 11 - 25 years) with standard risk GCT.

SECONDARY OBJECTIVES:

I. To compare the incidence of ototoxicity in children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin-based chemotherapy.

II. To refine and validate a novel patient-reported measure of hearing outcomes for children, adolescents and young adults with standard risk germ cell tumors.

III. To assess the utility of using an established panel of four circulating micro ribonucleic acid (RNA)s as a universal marker of diagnosis, recurrence and response to therapy.

IV. To identify novel genetic variants associated with an increased risk of platinum-associated ototoxicity as determined by standard audiology at the end of therapy using both a candidate gene and genome wide approach.

TERTIARY OBJECTIVES:

I. To prospectively determine the correlation of tumor marker decline (alpha-FP and beta-HCG) with clinical outcome in low and standard risk germ cell tumor patients.

II. To prospectively determine the clinical significance of activation of the BMP, Ras/MAPK and PI3K/mTOR signaling pathways in GCTs.

III. To investigate the prognostic significance of an established panel of four circulating microRNAs at diagnosis, during follow-up and at relapse in malignant GCTs.

IV. To identify integrated messenger RNA/microRNA profiles in primary malignant GCTs that correlate with poor clinical outcome.

V. To evaluate the significance of tumor deoxyribonucleic acid (DNA) methylation class.

VI. To characterize the incidence of nephrotoxicity in children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy and treated with cisplatin-based chemotherapy.

VII. To compare self-reported peripheral neuropathy and other patient-reported outcomes between children, adolescents and young adults with standard risk germ cell tumors treated with carboplatin-based chemotherapy as compared to cisplatin based chemotherapy.

VIII. To determine the utility of novel biomarkers of kidney tubular injury to provide earlier diagnosis of nephrotoxicity and to compare the nephrotoxicity of cisplatin versus carboplatin.

IX. Identify novel genetic variants of platinum neurotoxicity, nephrotoxicity and hematologic toxicity using both a candidate gene and whole gene approach.

X. Assess the relationship between hearing loss as measured by audiometry with the effects of tinnitus as assessed on the Adolescents and Young Adults-Hearing Screen (AYA-HEARS) instrument.

OUTLINE:

Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I malignant germ cell tumors undergo observation and can transfer to standard risk arm when eligibility criteria are met.

Patients with standard risk 1 are randomized into 1 of 2 arms.

ARM I (CEb): Patients receive bleomycin intravenously (IV) over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II (PEb): Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients with standard risk 2 are randomized into 1 of 2 arms.

ARM III (BEC): Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

ARM IV (BEP): Patients receive bleomycin sulfate IV over 10 minutes on days 1, 8, 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly to 12 months, every 2 months to 24 months, every 6 months for years 3-5, and then annually for up to 10 years.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Childrens Oncology Group

Principal Investigator
A. Lindsay Frazier

Trial IDs

Primary ID AGCT1531
Secondary IDs NCI-2017-00178
Clinicaltrials.gov ID NCT03067181