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Accelerated or Standard BEP Chemotherapy in Treating Patients with Intermediate or Poor-Risk Metastatic Germ Cell Tumors

Trial Status: Active

This randomized phase III trial studies how well an accelerated schedule of bleomycin sulfate, etoposide phosphate, and cisplatin (BEP) chemotherapy works compared to the standard schedule of BEP chemotherapy in treating patients with intermediate or poor-risk germ cell tumors that have spread to other places in the body (metastatic). Drugs used in chemotherapy, such as bleomycin sulfate, etoposide phosphate, 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. Giving BEP chemotherapy on a faster, or “accelerated” schedule may work better with fewer side effects in treating patients with intermediate or poor-risk metastatic germ cell tumors compared to the standard schedule.

Inclusion Criteria

  • Histologically or cytologically confirmed germ cell tumor (non-seminoma or seminoma); or exceptionally raised tumor markers (alpha-fetoprotein [AFP] >= 1000 ng/mL and/or human chorionic gonadotropin [HCG] >= 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with germ cell tumor (GCT), high tumor burden, and a need to start therapy urgently
  • Primary arising in testis, ovary, retro-peritoneum, or mediastinum
  • Metastatic disease or non-testicular primary
  • Intermediate or poor prognosis as defined by International Germ Cell Cancer Consensus Classification (IGCCC) classification (modified with different lactate dehydrogenase [LDH] criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries); see below * Primary site: Testis or retro-peritoneum or mediastinum ** Histology: Non-seminoma *** Prognostic category: Intermediate **** Clinical Factors: Testes/retroperitoneal primary and no liver, bone, brain or other non-pulmonary visceral metastases and intermediate markers – any of: ***** AFP >= 1000 ng/mL and =< 10 000 ng/mL ***** HCG >= 5000 IU/L and =< 50 000 IU/L ***** LDH >= 3.0 x upper limit of normal (ULN) and =< 10 x ULN *** Prognostic category: Poor **** Clinical Factors: Mediastinal primary or liver, bone, brain or other non-pulmonary visceral metastases or poor markers – any of: ***** AFP > 10 000 ng/mL or ***** HCG > 50 000 IU/L or ***** LDH > 10 x ULN ** Histology: Seminoma *** Prognostic category: Intermediate **** Clinical factors: Any primary site and liver, bone, brain or other non-pulmonary visceral metastases and normal AFP, any HCG, any LDH * Primary site: Ovary ** Histology: Malignant germ cell tumour histology (any of yolk sac, choriocarcinoma, embryonal carcinoma, mixed malignant GCT) *** Prognostic category: Federation of Gynecology and Obstetrics (FIGO)/Children's Oncology Group (COG) stage IV **** Distant metastases involving liver/spleen parenchyma and/or extra-abdominal organs (including but not limited to inguinal lymph nodes and lymph nodes outside abdominal cavity, lungs, bone, brain) and/or pleural effusion with positive cytology
  • Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
  • Platelet count >= 100 x 10^9/L
  • Bilirubin must be =< 1.5 x ULN, except participants with Gilbert’s syndrome where bilirubin must be =< 2.0 x ULN
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be =< 2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be =< 5 x ULN
  • Estimated creatinine clearance of >= 60 ml/min according to the Cockcroft-Gault formula, unless calculated to be < 60 ml/min or borderline in which case glomerular filtration rate (GFR) should be formally measured, e.g. with edetic acid (EDTA) scan
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3
  • Study treatment both planned and able to start within 14 days of randomization
  • Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments
  • Able to provide signed, written informed consent

Exclusion Criteria

  • Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumor, or other malignancy treated at least 5 years previously with no evidence of recurrence)
  • Previous chemotherapy or radiotherapy, except: * Pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin * Non-seminoma and poor prognosis by IGCCC criteria in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (e.g. organ failure, vena cava obstruction, overwhelming burden of disease); acceptable regimens include cisplatin 20 mg/m^2 days 1-2 and etoposide 100 mg/m^2 days 1-2; carboplatin area under curve (AUC) 3 days 1-2 and etoposide 100 mg/m^2 days 1-2; or baby-BOP; patients must meet all other inclusion and exclusion criteria at the time of registration * Participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomization; such patients must be discussed with the coordinating center prior to registration, and must be registered within 10 days of commencing study chemotherapy
  • Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
  • Significant co-morbid respiratory disease that contraindicates the use of bleomycin
  • Peripheral neuropathy >= grade 2 or clinically significant sensorineural hearing loss or tinnitus
  • Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
  • Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation; women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration
  • Known allergy or hypersensitivity to any of the study drugs
  • Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse

Alabama

Birmingham
Children's Hospital of Alabama
Status: ACTIVE
Contact: Site Public Contact
Phone: 205-638-9285

Alaska

Anchorage
Providence Alaska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871

Arizona

Phoenix
Phoenix Childrens Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 602-546-0920

Arkansas

Little Rock
Arkansas Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 501-364-7373

California

Downey
Kaiser Permanente Downey Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 626-564-3455
Loma Linda
Loma Linda University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 909-558-3375
Long Beach
Miller Children's and Women's Hospital Long Beach
Status: ACTIVE
Contact: Site Public Contact
Phone: 562-933-5600
Los Angeles
Children's Hospital Los Angeles
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-361-4110
Mattel Children's Hospital UCLA
Status: ACTIVE
Contact: Site Public Contact
Phone: 310-825-6708
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
Madera
Valley Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 559-353-3000
Oakland
Kaiser Permanente-Oakland
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Orange
Children's Hospital of Orange County
Status: ACTIVE
Contact: Site Public Contact
Phone: 714-997-3000
Palo Alto
Lucile Packard Children's Hospital Stanford University
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-694-0012
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-734-3089
San Diego
Rady Children's Hospital - San Diego
Status: ACTIVE
Contact: Site Public Contact
Phone: 858-966-5934
San Francisco
UCSF Medical Center-Mission Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-827-3222
Torrance
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 310-222-3624

Colorado

Aurora
Children's Hospital Colorado
Status: IN_REVIEW
Contact: Site Public Contact
Phone: 303-764-5056
Denver
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-839-6000

Connecticut

Hartford
Connecticut Children's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 860-545-9981
New Haven
Yale University
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702

Delaware

Wilmington
Alfred I duPont Hospital for Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-651-6884

District of Columbia

Washington
Children's National Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 202-884-2549
MedStar Georgetown University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 202-444-2223

Florida

Fort Lauderdale
Broward Health Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 954-355-5346
Fort Myers
Golisano Children's Hospital of Southwest Florida
Status: ACTIVE
Contact: Site Public Contact
Phone: 239-343-5333
Gainesville
University of Florida Health Science Center - Gainesville
Status: ACTIVE
Contact: Site Public Contact
Phone: 352-273-8010
Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 954-265-1847
Email: OHR@mhs.net
Jacksonville
Nemours Children's Clinic-Jacksonville
Status: ACTIVE
Contact: Site Public Contact
Phone: 904-697-3529
Miami
Nicklaus Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-624-2778
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Orlando
Arnold Palmer Hospital for Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 321-843-2584
Nemours Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 407-650-7150
Pensacola
Sacred Heart Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 850-416-4611
Saint Petersburg
Johns Hopkins All Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 727-767-4784
Tampa
Saint Joseph's Hospital / Children's Hospital-Tampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 813-356-7168
West Palm Beach
Saint Mary's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 561-881-2815

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-785-2025
Augusta
Augusta University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 706-721-2388
Savannah
Memorial Health University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-350-7887

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-983-6090

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774

Illinois

Chicago
Lurie Children's Hospital-Chicago
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-880-4562
University of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-355-3046
Oak Lawn
Advocate Children's Hospital-Oak Lawn
Status: ACTIVE
Contact: Site Public Contact
Phone: 847-723-7570
Park Ridge
Advocate Children's Hospital-Park Ridge
Status: ACTIVE
Contact: Site Public Contact
Peoria
Saint Jude Midwest Affiliate
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-226-4343

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632
Riley Hospital for Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-248-1199

Iowa

Des Moines
Blank Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-8912
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-237-1225

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
Norton Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 502-629-5500

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-703-8712

Maine

Bangor
Eastern Maine Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 207-973-4274

Maryland

Baltimore
Sinai Hospital of Baltimore
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-601-6120
Bethesda
Walter Reed National Military Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 301-319-2100

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-442-3324
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-726-5130

Michigan

Ann Arbor
C S Mott Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
Detroit
Ascension Saint John Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Kalamazoo
Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Royal Oak
Beaumont Children's Hospital-Royal Oak
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695

Minnesota

Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
Status: ACTIVE
Contact: Site Public Contact
Phone: 612-813-5193
University of Minnesota / Masonic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 612-624-2620
Rochester
Mayo Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015

Mississippi

Jackson
University of Mississippi Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Kansas City
Children's Mercy Hospitals and Clinics
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-302-6808
Email: rryan@cmh.edu
Saint Louis
Cardinal Glennon Children's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-268-4000
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606

Nevada

Las Vegas
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-996-2879
Morristown
Morristown Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 973-971-5900
New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-235-8675
Saint Peter's University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-745-8600ext6163

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-767-9355
Mineola
NYU Winthrop Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 516-663-3115
New York
NYP / Weill Cornell Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-746-1848
Syracuse
State University of New York Upstate Medical University
Status: ACTIVE
Contact: Site Public Contact
Phone: 315-464-5476
Valhalla
New York Medical College
Status: ACTIVE
Contact: Site Public Contact
Phone: 914-594-3794

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-668-0683
Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Durham
Duke University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-275-3853
Winston-Salem
Wake Forest University Health Sciences
Status: APPROVED
Contact: Site Public Contact
Phone: 336-713-6771

Ohio

Akron
Children's Hospital Medical Center of Akron
Status: ACTIVE
Contact: Site Public Contact
Phone: 330-543-3193
Cincinnati
Cincinnati Children's Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-636-2799
Cleveland
Cleveland Clinic Foundation
Status: APPROVED
Contact: Site Public Contact
Phone: 866-223-8100
Columbus
Nationwide Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-072-2657
Toledo
The Toledo Hospital / Toledo Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-824-1842

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Portland
Legacy Emanuel Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-2560
Oregon Health and Science University
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-494-1080

Pennsylvania

Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Philadelphia
Children's Hospital of Philadelphia
Status: ACTIVE
Contact: Site Public Contact
Phone: 267-425-5544
Childrens Oncology Group
Status: ACTIVE
Contact: Farzana Pashankar
Phone: 203-785-5702
Saint Christopher's Hospital for Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 215-427-8991
Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-692-8570

Puerto Rico

Caguas
HIMA San Pablo Oncologic Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 787-653-3434

Rhode Island

Providence
Rhode Island Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 401-444-1488

South Carolina

Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Phone: 843-792-9321
Columbia
Prisma Health Richland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 803-434-3533
Greenville
BI-LO Charities Children's Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Knoxville
East Tennessee Childrens Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 865-541-8266
Memphis
St. Jude Children's Research Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-278-5833
Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Austin
Dell Children's Medical Center of Central Texas
Status: ACTIVE
Contact: Site Public Contact
Phone: 512-628-1902
Dallas
Medical City Dallas Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 972-566-5588
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Site Public Contact
Phone: 214-648-7097
El Paso
El Paso Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 915-298-5444
Fort Worth
Cook Children's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 682-885-2103
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 713-798-1354
San Antonio
Children's Hospital of San Antonio
Status: ACTIVE
Contact: Site Public Contact
Methodist Children's Hospital of South Texas
Status: ACTIVE
Contact: Site Public Contact
Phone: 210-575-6240
University of Texas Health Science Center at San Antonio
Status: ACTIVE
Contact: Site Public Contact
Phone: 210-450-3800

Utah

Salt Lake City
Primary Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-585-5270

Virginia

Norfolk
Children's Hospital of The King's Daughters
Status: ACTIVE
Contact: Site Public Contact
Phone: 757-668-7243
Portsmouth
Naval Medical Center - Portsmouth
Status: ACTIVE
Contact: Site Public Contact
Phone: 757-953-5939
Roanoke
Carilion Clinic Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 540-266-6238

Washington

Seattle
Seattle Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-987-2000
Spokane
Providence Sacred Heart Medical Center and Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-228-6618
Tacoma
Madigan Army Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-968-0129

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-622-8922
Marshfield
Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Milwaukee
Children's Hospital of Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-955-4727

Alberta

Edmonton
University of Alberta Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 780-407-6615

Nova Scotia

Halifax
IWK Health Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 902-470-6767

Quebec

Montreal
Centre Hospitalier Universitaire Sainte-Justine
Status: ACTIVE
Contact: Site Public Contact
Phone: 514-345-4931
The Montreal Children's Hospital of the MUHC
Status: ACTIVE
Contact: Site Public Contact
Phone: 514-412-4445
Quebec
Centre Hospitalier Universitaire de Quebec
Status: ACTIVE
Contact: Site Public Contact
Phone: 418-525-4444

PRIMARY OBJECTIVE:

I. To compare the two treatment arms with respect to progression-free survival (disease progression or death).

SECONDARY OBJECTIVES:

I. To compare the two treatment arms with respect to:

Ia. Response following treatment completion (protocol-specific response criteria).

Ib. Adverse events (worst grade according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.03).

Ic. Health-related quality of life (summary scales from Quality of Life Questionnaire [QLQ]-C30 & -Testicular Cancer [TC]-26).

Id. Treatment preference (proportion preferring each treatment arm).

Ie. Delivered dose-intensity of chemotherapy (relative to standard BEP).

If. Overall survival (death from any cause).

CORRELATIVE OBJECTIVES:

I. Determine associations between biomarkers to be specified and their correlations with clinical outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive bleomycin sulfate intravenously (IV) over 10 minutes on days 1, 8, and 15 or 2, 9, and 16, etoposide phosphate IV over 1-2 hours once daily (QD) on days 1-5, cisplatin IV over 1-3 hours QD on days 1-5, and pegfilgrastim subcutaneously (SC) or filgrastim on day 6. Cycles repeat every 21 days for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving fewer than 8 doses of bleomycin sulfate due to pulmonary toxicity receive ifosfamide IV, mesna IV, etoposide phosphate IV, and cisplatin IV on days 1-5 and pegfilgrastim SC on day 6. Cycles repeat every 21 days for 12 weeks in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive bleomycin sulfate IV over 10 minutes on days 1 and 8 or 2 and 9, etoposide phosphate IV over 1-2 hours QD on days 1-5, cisplatin IV over 1-3 hours QD on days 1-5, and pegfilgrastim SC or filgrastim on day 6. Cycles repeat every 14 days for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients receiving fewer than 8 doses of bleomycin sulfate due to pulmonary toxicity receive ifosfamide IV, mesna IV, etoposide phosphate IV, and cisplatin IV on days 1-5 and pegfilgrastim SC on day 6. Cycles repeat every 21 days for 12 weeks in the absence of disease progression or unacceptable toxicity. After 12 weeks, patients then receive bleomycin sulfate IV over 60 minutes weekly for 4 doses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months, annually until disease progression, and then every 6 months after disease progression.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Childrens Oncology Group

Principal Investigator
Farzana Pashankar

  • Primary ID AGCT1532
  • Secondary IDs NCI-2017-00559
  • Clinicaltrials.gov ID NCT02582697