Radiation Therapy and Cisplatin with or without Triapine in Treating Patients with Newly Diagnosed Stage IB2, II, or IIIB-IVA Cervical Cancer or Stage II-IVA Vaginal Cancer

< Back to search results
This clinical trial matches:
Show Search Criteria
Status: Active

Description

This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as 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. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

Eligibility Criteria

Inclusion Criteria

  • Patient has a new, unrated histologic diagnosis of stage IB2 (> 5 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone ; the presence or absence of para‐aortic lymph node metastasis will be based on pre-therapy 18F‐FDG PET/CT; if the baseline 18F‐FDG PET/CT identifies hypermetabolic para‐aortic disease, such patients will NOT be eligible; the patient must be able to tolerate imaging requirements of an 18F‐FDG PET/CT scan
  • Patient must provide study specific informed consent prior to study entry
  • Patient must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 or equivalent
  • Absolute neutrophil count > 1,500/uL
  • Platelets > 100,000/uL
  • Hemoglobin > 10 g/dL
  • Total bilirubin < 2.0 mg/dL
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal
  • Prothrombin time (PT)/activated partial thromboplastin time (aPTT) < 1.5 X institutional upper limit of normal
  • Creatinine =< 1.5 mg/dL to receive weekly cisplatin * Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if the estimated creatinine clearance (CCr) is >= 30 ml/min; for the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used
  • Patient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose > 200 mg/dL)
  • Patient has a life expectancy of greater than 20 weeks
  • Patient does not have known brain metastases (testing optional)
  • Patient does not have known human immunodeficiency virus syndrome (HIV, testing optional); known HIV-positive patients receiving combination antiretroviral therapy are ineligible
  • Patient does not have a known allergy to compounds of similar or biologic composition as triapine
  • Patient does not have known glucose‐6‐phosphate dehydrogenase (G6PD) deficiency (G6PD testing optional)
  • Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy)

Exclusion Criteria

  • Patient has another concurrent active invasive malignancy
  • Patient has had a prior invasive malignancy diagnosed within the last three years (except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix); patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician
  • Patient has uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within six months of protocol initiation, cardiac arrhythmia within six months of protocol initiation; known inadequately controlled hypertension; clinically significant pulmonary disease including dyspnea at rest, or patients requiring supplemental oxygen, or poor pulmonary reserve; proteinuria or clinically significant renal function impairment (baseline serum creatinine > 2 mg/dL); or psychiatric illness/social situations that would limit compliance with study requirements
  • Patient is receiving another investigational agent for the treatment of cancer
  • Patient is currently pregnant
  • Patient does not agree to use two forms of birth control if they are of child-bearing potential
  • Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy following radiation as part of their cervical cancer treatment are ineligible
  • Patients scheduled to be treated with adjuvant consolidation chemotherapy at the conclusion of their standard chemoradiation
  • Patients with self-reported or known diagnosis of G6PD deficiency

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 205-934-0220
Email: tmyrick@uab.edu

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Oncology and Hematology LLC
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Women's Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Associates in Radiation Medicine
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Oncology Centre
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Katmai Oncology Group
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Providence Alaska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Fairbanks
Fairbanks Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 907-458-3043
Email: cancerresearch@foundationhealth.org

Arizona

Tucson
Banner University Medical Center - Tucson
Status: Active
Contact: Site Public Contact
Email: aselegue@email.arizona.edu
University of Arizona Cancer Center-North Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-327-2873

Arkansas

Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Little Rock
University of Arkansas for Medical Sciences
Status: Active
Contact: Site Public Contact
Phone: 501-686-8274

California

Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 818-847-4793
Email: Najee.Boucher@providence.org
La Jolla
UC San Diego Moores Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 858-822-5354
Email: cancercto@ucsd.edu
Los Angeles
Los Angeles County-USC Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 323-865-0451
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-827-8839
Email: ucstudy@uci.edu
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 916-734-3089
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 530-582-6450

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Site Public Contact
Phone: 720-848-0650
Colorado Springs
Penrose-Saint Francis Healthcare
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers-Penrose
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Denver
Porter Adventist Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Lakewood
Saint Anthony Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Littleton
Littleton Adventist Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Longmont
Longmont United Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Pueblo
Saint Mary Corwin Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Thornton
Rocky Mountain Cancer Centers-Thornton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Delaware

Lewes
Beebe Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-645-3770
Email: Dmiskin@Beebehealthcare.org
Newark
Christiana Care Health System-Christiana Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Christiana Gynecologic Oncology LLC
Status: Temporarily closed to accrual
Contact: Gregory Andrew Masters
Phone: 302-733-6227
Delaware Clinical and Laboratory Physicians PA
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Helen F Graham Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Medical Oncology Hematology Consultants PA
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

Florida

Jacksonville
Mayo Clinic in Florida
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 855-776-0015
Tampa
Moffitt Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-679-0775
Email: canceranswers@moffitt.org

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 404-851-7115
Emory University Hospital / Winship Cancer Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-946-7447
Augusta
Augusta University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 706-721-2388
Email: ga_cares@augusta.edu
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: Active
Contact: Site Public Contact
Phone: 912-819-5704
Email: underberga@sjchs.org
Memorial Health University Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 912-350-7887
Email: clayter1@memorialhealth.com

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-2774
Email: eslinget@slhs.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Nampa
Saint Luke's Mountain States Tumor Institute - Nampa
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Post Falls
Kootenai Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org

Illinois

Carbondale
Memorial Hospital of Carbondale
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 618-457-5200
Email: clinical.research@sih.net
Chicago
John H Stroger Jr Hospital of Cook County
Status: Active
Contact: Site Public Contact
Phone: 312-864-5204
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Rush University Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 312-942-5498
Email: clinical_trials@rush.edu
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Decatur Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Effingham
Crossroads Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Galesburg
Western Illinois Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-344-2831
Geneva
Northwestern Medicine Cancer Center Delnor
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org
Maywood
Loyola University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357
Mount Vernon
Good Samaritan Regional Health Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 618-242-4600
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Radiation Oncology of Northern Illinois
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Pekin
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Methodist Medical Center of Illinois
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
OSF Saint Francis Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Valley Radiation Oncology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Springfield
Memorial Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-444-7541
Swansea
Cancer Care Specialists of Illinois-Swansea
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Southwest Illinois Health Services LLP
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 618-236-1000
Email: lynns@thecancercenter.com
Urbana
Carle Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org

Indiana

Fort Wayne
Parkview Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-784-4673
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu
Saint Vincent Hospital and Health Care Center
Status: Active
Contact: Site Public Contact
Phone: 317-338-2194
Email: research@stvincent.org
Sidney and Lois Eskenazi Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu
Richmond
Reid Health
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu

Iowa

Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Cancer Center-West Lakes
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Des Moines
Medical Oncology and Hematology Associates-Laurel
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Medical Center - Des Moines
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
West Des Moines
Mercy Medical Center-West Lakes
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Kansas

Garden City
Saint Catherine Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-592-5110
Email: info@cccancer.com
Great Bend
Saint Rose Ambulatory and Surgery Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 620-792-5511

Kentucky

Lexington
Saint Joseph Hospital East
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Saint Joseph Radiation Oncology Resource Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
University of Kentucky / Markey Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
Jewish Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Jewish Hospital Medical Center Northeast
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
The James Graham Brown Cancer Center at University of Louisville
Status: Active
Contact: Site Public Contact
Phone: 502-562-3429

Louisiana

Metairie
East Jefferson General Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu
New Orleans
Ochsner Medical Center Jefferson
Status: Active
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org
University Medical Center New Orleans
Status: Active
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Farmington Hills
Weisberg Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 313-576-9790
Email: ctoadmin@karmanos.org
Grand Rapids
Mercy Health Saint Mary's
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Spectrum Health at Butterworth Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Kalamazoo
Borgess Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Bronson Methodist Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
West Michigan Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Muskegon
Mercy Health Mercy Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Reed City
Spectrum Health Reed City Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Traverse City
Munson Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Wyoming
Metro Health Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Minnesota

Rochester
Mayo Clinic
Status: Temporarily closed to accrual
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

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-251-7058
Cape Girardeau
Saint Francis Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-651-5550
Jefferson City
Capital Region Southwest Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-632-4814
Email: swooden@mail.crmc.org
Joplin
Freeman Health System
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 417-347-4030
Email: LJCrockett@freemanhealth.com
Rolla
Delbert Day Cancer Institute at PCRMC
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Mercy Clinic-Rolla-Cancer and Hematology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Saint Louis
Mercy Hospital Saint Louis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-251-7066
Missouri Baptist Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
CoxHealth South Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 417-269-4520

Montana

Billings
Billings Clinic Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Saint Vincent Healthcare
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Bozeman
Bozeman Deaconess Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Butte
Saint James Community Hospital and Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-723-2621
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Kalispell
Kalispell Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Missoula
Community Medical Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Nebraska

Grand Island
CHI Health Saint Francis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Kearney
CHI Health Good Samaritan
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Omaha
Alegent Health Bergan Mercy Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Alegent Health Immanuel Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Alegent Health Lakeside Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Creighton University Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
University of Nebraska Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 402-559-6941
Email: unmcrsa@unmc.edu
Papillion
Midlands Community Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Nevada

Las Vegas
Radiation Oncology Centers of Nevada Central
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Women's Cancer Center of Nevada
Status: Active
Contact: Site Public Contact
Phone: 702-693-6870
Email: kmcwhirter@wccenter.com

New Jersey

Camden
Cooper Hospital University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 856-325-6757
Hackensack
Hackensack University Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 201-996-2879
Mount Holly
Virtua Memorial
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 609-914-6762
Mount Laurel
Cooper CyberKnife Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 855-632-2667
Email: research-cancer@cooperhealth.edu
Voorhees
MD Anderson Cancer Center at Cooper-Voorhees
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 856-325-6757
Virtua Voorhees
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 856-247-7395

New Mexico

Albuquerque
Southwest Gynecologic Oncology Associates Inc
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 505-272-0530
Email: RDraper@nmcca.org
University of New Mexico Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org
Las Cruces
Memorial Medical Center - Las Cruces
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 575-556-6545
Email: Kim.Hoffman@lpnt.net

New York

Albany
Saint Peter's Health Partners
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 518-525-6739
Email: CancerCareResearch@sphp.com
Buffalo
Roswell Park Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-767-9355
Email: askroswell@roswellpark.org
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Site Public Contact
Phone: 212-263-4434
Email: prmc.coordinator@nyumc.org
Mount Sinai Chelsea
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Rochester
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
Syracuse
State University of New York Upstate Medical University
Status: Active
Contact: Site Public Contact
Phone: 315-464-5476

Ohio

Beachwood
UHHS-Chagrin Highlands Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Centerville
Miami Valley Hospital South
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Chillicothe
Adena Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 877-779-7585
Email: sheree@columbusccop.org
Cincinnati
Bethesda North Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Good Samaritan Hospital - Cincinnati
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Oncology Hematology Care Inc-Blue Ash
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-649-4800
University of Cincinnati / Barrett Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 513-558-4553
Email: uchealthnews@uc.edu
Cleveland
Case Western Reserve University
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Cleveland Clinic Cancer Center / Fairview Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Cleveland Clinic Foundation
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
MetroHealth Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 216-778-8526
Email: dstrater@metrohealth.org
Columbus
Doctors Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-566-3275
Email: sheree@columbusccop.org
Grant Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
Mount Carmel East Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Mount Carmel Health Center West
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
Riverside Methodist Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-566-4475
Email: sheree@columbusccop.org
The Mark H Zangmeister Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Dayton
Dayton Physician LLC-Miami Valley Hospital North
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Good Samaritan Hospital - Dayton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Miami Valley Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Miami Valley Hospital North
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Delaware
Delaware Radiation Oncology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Grady Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 740-615-2403
Email: sheree@columbusccop.org
Findlay
Blanchard Valley Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Franklin
Atrium Medical Center-Middletown Regional Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Greenville
Wayne Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Kettering
Kettering Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Mansfield
OhioHealth Mansfield Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 419-526-8018
Email: sheree@columbusccop.org
Marietta
Marietta Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-523-3977
Email: sheree@columbusccop.org
Mayfield Heights
Hillcrest Hospital Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Mentor
UH Seidman Cancer Center at Lake Health Mentor Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Newark
Licking Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 740-348-4000
Email: sheree@columbusccop.org
Newark Radiation Oncology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Portsmouth
Southern Ohio Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-488-2118
Email: sheree@columbusccop.org
Springfield
Springfield Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Sylvania
ProMedica Flower Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 419-824-1842
Toledo
The Toledo Hospital / Toledo Children's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 419-824-1842
Troy
Upper Valley Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 937-775-1350
Email: som_dcop@wright.edu
Westerville
Saint Ann's Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 614-234-5433
Email: sheree@columbusccop.org
Westlake
UHHS-Westlake Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Zanesville
Genesis Healthcare System Cancer Care Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 740-454-5232
Email: sheree@columbusccop.org

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Bend
Saint Charles Health System
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 541-706-2909
Email: nosall@stcharleshealthcare.org
Clackamas
Clackamas Radiation Oncology Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Coos Bay
Bay Area Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 541-269-8392
Email: cherie.cox@bayareahospital.org
Portland
Providence Portland Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

Pennsylvania

Chadds Ford
Christiana Care Health System-Concord Health Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Dunmore
Northeast Radiation Oncology Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 888-808-6762
Philadelphia
Thomas Jefferson University Hospital
Status: Active
Contact: Site Public Contact
Phone: 215-955-6084
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 412-647-8073
UPMC-Magee Womens Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-647-2811
West Reading
Reading Hospital
Status: Active
Contact: Site Public Contact
Phone: 610-988-9323

Puerto Rico

San Juan
Centro Comprensivo de Cancer de UPR
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
San Juan City Hospital
Status: Active
Contact: Site Public Contact
Phone: 787-763-1296
San Juan Community Oncology Group
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 787-274-3387

Rhode Island

Providence
Women and Infants Hospital
Status: Active
Contact: Site Public Contact
Phone: 401-274-1122

South Carolina

Greenville
Greenville Health System Cancer Institute-Faris
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Saint Francis Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 864-603-6213
Email: meissa_beckman@bshsi.org
Saint Francis Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 864-603-6213
Email: meissa_beckman@bshsi.org
Spartanburg
Spartanburg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org

Tennessee

Chattanooga
Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Nashville
Vanderbilt University / Ingram Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Bryan
Saint Joseph Regional Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Dallas
Parkland Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 214-590-5582
Email: canceranswerline@UTSouthwestern.edu
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
Houston
Memorial Hermann Texas Medical Center
Status: Active
Contact: Site Public Contact
Phone: 713-792-3245
The Methodist Hospital System
Status: Active
Contact: Site Public Contact
Phone: 713-790-2700
Sugar Land
Houston Methodist Sugar Land Hospital
Status: Active
Contact: Site Public Contact
Phone: 281-242-2873

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Auburn
MultiCare Auburn Medical Center
Status: Active
Contact: Site Public Contact
Phone: 253-887-9333
Email: research@multicare.org
Bellevue
Overlake Hospital Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 425-688-5407
Email: OHMCResearch@overlakehospital.org
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-715-4133
Email: mjohnson9@peacehealth.org
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Harrison Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Burien
Highline Medical Center-Main Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Centralia
Providence Regional Cancer System-Centralia
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Everett
Providence Regional Cancer Partnership
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 425-261-3529
Email: marilyn.birchman@providence.org
Federal Way
Virginia Mason Federal Way Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 206-342-6954
Email: vmmc.cancer_clinical_research@VirginiaMason.org
Gig Harbor
MultiCare Gig Harbor Medical Park
Status: Active
Contact: Site Public Contact
Phone: 253-403-2394
Email: research@multicare.org
Tacoma / Valley Radiation Oncology Centers-Gig Harbor
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 253-851-5155
Email: info@tacomaradiation.com
Issaquah
Swedish Cancer Institute-Issaquah
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Lacey
Providence Regional Cancer System-Lacey
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Longview
PeaceHealth Saint John Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-514-2016
Email: kmakin-bond@peacehealth.org
Puyallup
MultiCare Good Samaritan Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-351-7955
Email: research@multicare.org
Tacoma / Valley Radiation Oncology Centers-Puyallup
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 253-841-4311
Email: info@tacomaradiation.com
Seattle
Swedish Medical Center-First Hill
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Virginia Mason Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 206-342-6954
Email: vmmc.cancer_clinical_research@VirginiaMason.org
Tacoma
MultiCare Tacoma General Hospital
Status: Active
Contact: Site Public Contact
Phone: 253-403-3229
Email: research@multicare.org
Northwest Medical Specialties PLLC
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Tacoma / Valley Radiation Oncology Centers-Saint Joe's
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 253-272-1077
Email: info@tacomaradiation.com
Vancouver
PeaceHealth Southwest Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-514-3940
Email: kmakin-bond@peacehealth.org
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 509-897-5993
Email: Cheryl.Dodd@providence.org
Yakima
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 509-574-3535
Email: Memorial-ClinicalTrials@yvmh.org

West Virginia

Morgantown
West Virginia University Healthcare
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu
Wheeling
Wheeling Hospital / Schiffler Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 304-243-6442

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-622-8922
Marshfield
Marshfield Medical Center-Marshfield
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
Milwaukee
Froedtert and the Medical College of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-805-4380
Stevens Point
Marshfield Clinic Stevens Point Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase progression-free survival relative to the standard/control regimen of cisplatin and radiation in women with uterine cervix or vaginal cancer.

SECONDARY OBJECTIVES:

I. To determine the post-therapy 3-month fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) metabolic complete response rate in the uterine cervix and vaginal by treatment arm.

II. To determine overall survival after triapine-cisplatin radio-chemotherapy and cisplatin radio-chemotherapy.

TERTIARY OBJECTIVES:

I. To evaluate incidence and severity of hematologic and gastrointestinal (GI) adverse events by radiation modality; image guided intensity modulated radiation therapy (IG-IMRT) versus conventional pelvic radiotherapy.

II. To summarize and compare differences in acute adverse events (Common Terminology Criteria for Adverse Events [CTCAE], version [v]4.0) by treatment arm and by radiation modality.

III. To summarize and compare differences in chronic or late (>= 30-days from off study treatment date) adverse events (CTCAE, v4.0) by treatment arm and by radiation modality.

IV. To determine peripheral blood methemoglobin proportion before and after triapine infusion (optional for Arm 2 patients).

V. To explore whether knowledge-based planning (KBP) can improve IG-IMRT plans compared to plans that would have been delivered without KBP, estimate the resulting toxicity reduction using normal tissue complication probability (NTCP) models, and determine whether KBP should be a requirement for future IG-IMRT protocols.

VI. To compare acute toxicity and chemotherapy delivery for atlas-based IG-IMRT vs. PET/CT-based IG-IMRT vs. conventional radiation therapy (RT), and assess the impact of treatment on changes in hematopoietic compensatory response.

VII. To develop and validate machine learning and radiomics techniques for dose accumulation, automated treatment planning, and prediction of treatment response.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin intravenously (IV) over 90 minutes on days 2, 9, 16, 23, 30, (and day 36 or 37 at the treating physician's discretion). Patients then undergo external beam radiation therapy (EBRT) (either conventional RT or intensity modulated radiation therapy [IMRT]) once daily (QD) 5 days a week for 25 fractions followed by low dose rate (LDR) or high dose rate (HDR) brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive cisplatin and undergo EBRT followed by brachytherapy as in Arm I. Patients also receive triapine IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 2 years, and then every 6 months for 3 years.

The patient data from NCI #9434 will be merged with NRG-GY006 per the Protocol Analysis Plan.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
Charles A. Leath

Trial IDs

Primary ID NRG-GY006
Secondary IDs NCI-2015-00835
Clinicaltrials.gov ID NCT02466971