A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination With Intravenous Triapine in Women With Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

Who is this study for? Adult female patients with Stage IB2, II, IIIB, or IVA Cervical
Status: Active_not_recruiting
Location: See all (382) locations...
Intervention Type: Radiation, Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient has a new, unrated histologic diagnosis of stage IB2 (\> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) 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; NOTE: 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 because of the potential for pharmacokinetic interactions with triapine

• 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 as the condition interferes with triapine antidote metabolism (G6PD testing optional)

• Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy)

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska Oncology and Hematology LLC
Anchorage
Alaska Women's Cancer Care
Anchorage
Anchorage Associates in Radiation Medicine
Anchorage
Anchorage Oncology Centre
Anchorage
Katmai Oncology Group
Anchorage
Providence Alaska Medical Center
Anchorage
Fairbanks Memorial Hospital
Fairbanks
Alabama
University of Alabama at Birmingham Cancer Center
Birmingham
Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs
University of Arkansas for Medical Sciences
Little Rock
Arizona
Banner University Medical Center - Tucson
Tucson
University of Arizona Cancer Center-North Campus
Tucson
California
Kaiser Permanente-Deer Valley Medical Center
Antioch
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
Kaiser Permanente-Fremont
Fremont
Kaiser Permanente-Fresno
Fresno
UC San Diego Moores Cancer Center
La Jolla
Los Angeles General Medical Center
Los Angeles
Kaiser Permanente-Modesto
Modesto
Kaiser Permanente Oakland-Broadway
Oakland
Kaiser Permanente-Oakland
Oakland
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova
Kaiser Permanente-Redwood City
Redwood City
Kaiser Permanente-Richmond
Richmond
Rohnert Park Cancer Center
Rohnert Park
Kaiser Permanente-Roseville
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Roseville
Kaiser Permanente Sacramento Medical Center
Sacramento
Kaiser Permanente-South Sacramento
Sacramento
South Sacramento Cancer Center
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
Kaiser Permanente-San Francisco
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
San Jose
Kaiser Permanente San Leandro
San Leandro
Kaiser Permanente-San Rafael
San Rafael
Kaiser San Rafael-Gallinas
San Rafael
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
Kaiser Permanente-Santa Rosa
Santa Rosa
Kaiser Permanente Cancer Treatment Center
South San Francisco
Kaiser Permanente-South San Francisco
South San Francisco
Kaiser Permanente-Stockton
Stockton
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee
Kaiser Permanente Medical Center-Vacaville
Vacaville
Kaiser Permanente-Vallejo
Vallejo
Kaiser Permanente-Walnut Creek
Walnut Creek
Colorado
UCHealth University of Colorado Hospital
Aurora
Penrose-Saint Francis Healthcare
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
Colorado Springs
AdventHealth Porter
Denver
Saint Anthony Hospital
Lakewood
Littleton Adventist Hospital
Littleton
Longmont United Hospital
Longmont
Saint Mary Corwin Medical Center
Pueblo
Rocky Mountain Cancer Centers-Thornton
Thornton
Connecticut
Hartford Hospital
Hartford
Delaware
Beebe Medical Center
Lewes
Christiana Care Health System-Christiana Hospital
Newark
Delaware Clinical and Laboratory Physicians PA
Newark
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Florida
University of Florida Health Science Center - Gainesville
Gainesville
Mayo Clinic in Florida
Jacksonville
Lakeland Regional Health Hollis Cancer Center
Lakeland
Moffitt Cancer Center
Tampa
Georgia
Emory Saint Joseph's Hospital
Atlanta
Emory University Hospital Midtown
Atlanta
Emory University Hospital/Winship Cancer Institute
Atlanta
Augusta University Medical Center
Augusta
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah
Memorial Health University Medical Center
Savannah
Hawaii
Pali Momi Medical Center
'aiea
Queen's Cancer Center - Pearlridge
'aiea
The Cancer Center of Hawaii-Pali Momi
'aiea
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Hawaii Cancer Care Inc-Liliha
Honolulu
Island Urology
Honolulu
Kaiser Permanente Moanalua Medical Center
Honolulu
Kapiolani Medical Center for Women and Children
Honolulu
Kuakini Medical Center
Honolulu
Queen's Cancer Center - Kuakini
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
University of Hawaii Cancer Center
Honolulu
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue
Iowa
Mercy Hospital
Cedar Rapids
Oncology Associates at Mercy Medical Center
Cedar Rapids
Mercy Cancer Center-West Lakes
Clive
Mission Cancer and Blood - West Des Moines
Clive
Iowa Lutheran Hospital
Des Moines
Iowa Methodist Medical Center
Des Moines
Mercy Medical Center - Des Moines
Des Moines
Mission Cancer and Blood - Des Moines
Des Moines
Mission Cancer and Blood - Laurel
Des Moines
Mercy Medical Center-West Lakes
West Des Moines
Methodist West Hospital
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Saint Luke's Cancer Institute - Boise
Boise
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell
Saint Luke's Cancer Institute - Fruitland
Fruitland
Saint Luke's Cancer Institute - Meridian
Meridian
Saint Luke's Cancer Institute - Nampa
Nampa
Kootenai Clinic Cancer Services - Post Falls
Post Falls
Saint Luke's Cancer Institute - Twin Falls
Twin Falls
Illinois
OSF Saint Joseph Medical Center
Bloomington
Memorial Hospital of Carbondale
Carbondale
John H Stroger Jr Hospital of Cook County
Chicago
Northwestern University
Chicago
Rush University Medical Center
Chicago
Cancer Care Specialists of Illinois - Decatur
Decatur
Decatur Memorial Hospital
Decatur
Crossroads Cancer Center
Effingham
Western Illinois Cancer Treatment Center
Galesburg
Northwestern Medicine Cancer Center Delnor
Geneva
Loyola University Medical Center
Maywood
SSM Health Good Samaritan
Mount Vernon
Cancer Care Center of O'Fallon
O'fallon
Illinois CancerCare-Ottawa Clinic
Ottawa
Radiation Oncology of Northern Illinois
Ottawa
OSF Saint Francis Radiation Oncology at Pekin
Pekin
Illinois CancerCare-Peoria
Peoria
Methodist Medical Center of Illinois
Peoria
OSF Saint Francis Medical Center
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria
Illinois CancerCare-Peru
Peru
Valley Radiation Oncology
Peru
Illinois CancerCare-Princeton
Princeton
Central Illinois Hematology Oncology Center
Springfield
Southern Illinois University School of Medicine
Springfield
Springfield Clinic
Springfield
Springfield Memorial Hospital
Springfield
Southwest Illinois Health Services LLP
Swansea
Carle Cancer Center
Urbana
Northwestern Medicine Cancer Center Warrenville
Warrenville
Indiana
Parkview Hospital Randallia
Fort Wayne
Parkview Regional Medical Center
Fort Wayne
Ascension Saint Vincent Indianapolis Hospital
Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis
Sidney and Lois Eskenazi Hospital
Indianapolis
Reid Health
Richmond
Kansas
Saint Catherine Hospital
Garden City
Saint Rose Ambulatory and Surgery Center
Great Bend
HaysMed
Hays
University of Kansas Cancer Center
Kansas City
The University of Kansas Cancer Center - Olathe
Olathe
University of Kansas Cancer Center-Overland Park
Overland Park
Ascension Via Christi - Pittsburg
Pittsburg
Salina Regional Health Center
Salina
University of Kansas Health System Saint Francis Campus
Topeka
Kentucky
Saint Joseph Hospital East
Lexington
Saint Joseph Radiation Oncology Resource Center
Lexington
University of Kentucky/Markey Cancer Center
Lexington
Jewish Hospital
Louisville
The James Graham Brown Cancer Center at University of Louisville
Louisville
UofL Health Medical Center Northeast
Louisville
Louisiana
East Jefferson General Hospital
Metairie
Ochsner Medical Center Jefferson
New Orleans
University Medical Center New Orleans
New Orleans
Maryland
Greater Baltimore Medical Center
Baltimore
Walter Reed National Military Medical Center
Bethesda
Michigan
Henry Ford Cancer Institute-Downriver
Brownstown
Henry Ford Macomb Hospital-Clinton Township
Clinton Township
Henry Ford Hospital
Detroit
Wayne State University/Karmanos Cancer Institute
Detroit
Weisberg Cancer Treatment Center
Farmington Hills
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids
Trinity Health Grand Rapids Hospital
Grand Rapids
Ascension Borgess Hospital
Kalamazoo
Bronson Methodist Hospital
Kalamazoo
West Michigan Cancer Center
Kalamazoo
Trinity Health Muskegon Hospital
Muskegon
Corewell Health Reed City Hospital
Reed City
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph
Munson Medical Center
Traverse City
Henry Ford West Bloomfield Hospital
West Bloomfield
University of Michigan Health - West
Wyoming
Minnesota
University of Minnesota/Masonic Cancer Center
Minneapolis
Mayo Clinic in Rochester
Rochester
Missouri
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin
Saint Francis Medical Center
Cape Girardeau
Southeast Cancer Center
Cape Girardeau
MU Health Care Goldschmidt Cancer Center
Jefferson City
Freeman Health System
Joplin
North Kansas City Hospital
Kansas City
The University of Kansas Cancer Center-South
Kansas City
University of Kansas Cancer Center - North
Kansas City
University of Kansas Cancer Center - Lee's Summit
Lee's Summit
Delbert Day Cancer Institute at PCRMC
Rolla
Mercy Clinic-Rolla-Cancer and Hematology
Rolla
Mercy Hospital Saint Louis
Saint Louis
Missouri Baptist Medical Center
Saint Louis
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Mississippi
University of Mississippi Medical Center
Jackson
Montana
Billings Clinic Cancer Center
Billings
Saint Vincent Healthcare
Billings
Bozeman Health Deaconess Hospital
Bozeman
Saint James Community Hospital and Cancer Treatment Center
Butte
Benefis Sletten Cancer Institute
Great Falls
Great Falls Clinic
Great Falls
Logan Health Medical Center
Kalispell
Community Medical Center
Missoula
North Carolina
Novant Health Presbyterian Medical Center
Charlotte
Wake Forest University Health Sciences
Winston-salem
Nebraska
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island
CHI Health Good Samaritan
Kearney
Alegent Health Bergan Mercy Medical Center
Omaha
Alegent Health Immanuel Medical Center
Omaha
Alegent Health Lakeside Hospital
Omaha
Creighton University Medical Center
Omaha
Nebraska Methodist Hospital
Omaha
University of Nebraska Medical Center
Omaha
Midlands Community Hospital
Papillion
New Jersey
Cooper Hospital University Medical Center
Camden
Virtua Memorial
Mount Holly
Cooper CyberKnife Center
Mount Laurel
Rutgers Cancer Institute of New Jersey
New Brunswick
Rutgers New Jersey Medical School
Newark
Robert Wood Johnson University Hospital Somerset
Somerville
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees
Virtua Voorhees
Voorhees
New Mexico
Southwest Gynecologic Oncology Associates Inc
Albuquerque
University of New Mexico Cancer Center
Albuquerque
Memorial Medical Center - Las Cruces
Las Cruces
Nevada
Radiation Oncology Centers of Nevada Central
Las Vegas
Women's Cancer Center of Nevada
Las Vegas
Center of Hope at Renown Medical Center
Reno
Renown Regional Medical Center
Reno
New York
Saint Peter's Health Partners
Albany
Women's Cancer Care Associates LLC
Albany
Maimonides Medical Center
Brooklyn
Roswell Park Cancer Institute
Buffalo
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
Mount Sinai Chelsea
New York
Highland Hospital
Rochester
University of Rochester
Rochester
State University of New York Upstate Medical University
Syracuse
Ohio
Summa Health System - Akron Campus
Akron
UHHS-Chagrin Highlands Medical Center
Beachwood
Aultman Health Foundation
Canton
Miami Valley Hospital South
Centerville
Geauga Hospital
Chardon
Adena Regional Medical Center
Chillicothe
Bethesda North Hospital
Cincinnati
Good Samaritan Hospital - Cincinnati
Cincinnati
Oncology Hematology Care Inc-Blue Ash
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati
Case Western Reserve University
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland
Cleveland Clinic Foundation
Cleveland
MetroHealth Medical Center
Cleveland
Doctors Hospital
Columbus
Grant Medical Center
Columbus
Mount Carmel East Hospital
Columbus
Mount Carmel Health Center West
Columbus
Riverside Methodist Hospital
Columbus
The Mark H Zangmeister Center
Columbus
Dayton Physician LLC - Englewood
Dayton
Good Samaritan Hospital - Dayton
Dayton
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
Delaware Radiation Oncology
Delaware
Grady Memorial Hospital
Delaware
Blanchard Valley Hospital
Findlay
Atrium Medical Center-Middletown Regional Hospital
Franklin
Wayne Hospital
Greenville
Kettering Medical Center
Kettering
OhioHealth Mansfield Hospital
Mansfield
Marietta Memorial Hospital
Marietta
Hillcrest Hospital Cancer Center
Mayfield Heights
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor
Licking Memorial Hospital
Newark
Newark Radiation Oncology
Newark
Southern Ohio Medical Center
Portsmouth
Springfield Regional Medical Center
Springfield
ProMedica Flower Hospital
Sylvania
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo
Upper Valley Medical Center
Troy
University Hospitals Sharon Health Center
Wadsworth
University of Cincinnati Cancer Center-West Chester
West Chester
Saint Ann's Hospital
Westerville
UH Seidman Cancer Center at Saint John Medical Center
Westlake
UHHS-Westlake Medical Center
Westlake
Genesis Healthcare System Cancer Care Center
Zanesville
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa
Oregon
Saint Charles Health System
Bend
Clackamas Radiation Oncology Center
Clackamas
Bay Area Hospital
Coos Bay
Legacy Mount Hood Medical Center
Gresham
Legacy Good Samaritan Hospital and Medical Center
Portland
Oregon Health and Science University
Portland
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Legacy Meridian Park Hospital
Tualatin
Pennsylvania
Jefferson Abington Hospital
Abington
UPMC-Heritage Valley Health System Beaver
Beaver
Christiana Care Health System-Concord Health Center
Chadds Ford
Northeast Radiation Oncology Center
Dunmore
Ephrata Cancer Center
Ephrata
Adams Cancer Center
Gettysburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg
WellSpan Medical Oncology and Hematology
Hanover
UPMC Hillman Cancer Center in Coraopolis
Moon
Thomas Jefferson University Hospital
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
UPMC-Magee Womens Hospital
Pittsburgh
UPMC-Shadyside Hospital
Pittsburgh
Reading Hospital
West Reading
Asplundh Cancer Pavilion
Willow Grove
Lankenau Medical Center
Wynnewood
WellSpan Health-York Cancer Center
York
WellSpan Health-York Hospital
York
Rhode Island
Women and Infants Hospital
Providence
South Carolina
Prisma Health Cancer Institute - Faris
Greenville
Saint Francis Cancer Center
Greenville
Saint Francis Hospital
Greenville
Spartanburg Medical Center
Spartanburg
South Dakota
Rapid City Regional Hospital
Rapid City
Tennessee
Memorial Hospital
Chattanooga
Vanderbilt University/Ingram Cancer Center
Nashville
Texas
Saint Joseph Regional Cancer Center
Bryan
Parkland Memorial Hospital
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Houston Methodist Hospital
Houston
Memorial Hermann Texas Medical Center
Houston
Methodist Willowbrook Hospital
Houston
Houston Methodist Sugar Land Hospital
Sugar Land
Houston Methodist The Woodlands Hospital
The Woodlands
Utah
Sandra L Maxwell Cancer Center
Cedar City
Logan Regional Hospital
Logan
Intermountain Medical Center
Murray
McKay-Dee Hospital Center
Ogden
Utah Valley Regional Medical Center
Provo
Saint George Regional Medical Center
Saint George
Huntsman Cancer Institute/University of Utah
Salt Lake City
LDS Hospital
Salt Lake City
Utah Cancer Specialists-Salt Lake City
Salt Lake City
South Jordan Health Center
South Jordan
Washington
Providence Regional Cancer System-Aberdeen
Aberdeen
MultiCare Auburn Medical Center
Auburn
Overlake Medical Center
Bellevue
PeaceHealth Saint Joseph Medical Center
Bellingham
Highline Medical Center-Main Campus
Burien
Providence Regional Cancer System-Centralia
Centralia
Providence Regional Cancer Partnership
Everett
Virginia Mason Federal Way Medical Center
Federal Way
MultiCare Gig Harbor Medical Park
Gig Harbor
Tacoma/Valley Radiation Oncology Centers-Gig Harbor
Gig Harbor
Swedish Cancer Institute-Issaquah
Issaquah
Providence Regional Cancer System-Lacey
Lacey
PeaceHealth Saint John Medical Center
Longview
MultiCare Good Samaritan Hospital
Puyallup
Tacoma/Valley Radiation Oncology Centers-Puyallup
Puyallup
FHCC South Lake Union
Seattle
Kaiser Permanente Washington
Seattle
Swedish Medical Center-First Hill
Seattle
Virginia Mason Medical Center
Seattle
Saint Michael Cancer Center
Silverdale
MultiCare Tacoma General Hospital
Tacoma
Northwest Medical Specialties PLLC
Tacoma
Tacoma/Valley Radiation Oncology Centers-Saint Joe's
Tacoma
Legacy Salmon Creek Hospital
Vancouver
PeaceHealth Southwest Medical Center
Vancouver
Providence Saint Mary Regional Cancer Center
Walla Walla
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima
Wisconsin
Marshfield Medical Center-EC Cancer Center
Eau Claire
University of Wisconsin Carbone Cancer Center - University Hospital
Madison
Marshfield Medical Center-Marshfield
Marshfield
Medical College of Wisconsin
Milwaukee
Marshfield Medical Center - Minocqua
Minocqua
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
Marshfield Medical Center - Weston
Weston
West Virginia
Edwards Comprehensive Cancer Center
Huntington
West Virginia University Healthcare
Morgantown
Wheeling Hospital/Schiffler Cancer Center
Wheeling
Other Locations
Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto
Puerto Rico
Centro Comprensivo de Cancer de UPR
San Juan
San Juan City Hospital
San Juan
San Juan Community Oncology Group
San Juan
Time Frame
Start Date: 2016-05-10
Completion Date: 2025-10-02
Participants
Target number of participants: 450
Treatments
Active_comparator: Arm I (cisplatin, IMRT or RT, brachytherapy)
Patients receive cisplatin 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 EBRT (either conventional RT or IMRT) QD 5 days a week for 25 fractions followed by LDR or HDR brachytherapy according to institution's standards. Treatment continues in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (cisplatin, IMRT or RT, brachytherapy, triapine)
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.
Authors
Sharon Robertson, Kathleen J. Yost, Merry J. Markham, Deborah W. Wilbur, Sinisa Stanic, Kristine M. Zanotti, Kristin K. Zorn, Valentin G. Kolev, David P. Warshal, Heidi J. Gray, Michael P. Hopkins, Bryan A. Faller, Amelia M. Jernigan, Samuel S. Lentz, Mark S. Shahin, Ramey D. Littell, Matthew M. Harkenrider, Howard M. Gross, Jay W. Carlson, Hye Sook Chon, Mehmet S. Copur, Leslie R. Boyd, David S. Miller, Loren K. Mell, Mildred R. Ridgway, Steven E. Waggoner, Howard A. Zaren, Katrina S. Wade, Charles Leath, Mihae Song, Robert B. Den, Parul N. Barry, Thomas E. Lad, Jeanne M. Schilder, Kimberly E. Resnick, Krishna C. Alluri, John M. Schallenkamp, Jeffrey H. Muler, Patricia K. Lillis, Carlton L. Schwab, Namita Khanna, Tarrik M. Zaid, Brent J. Tierney, Heather R. Williams, Iwona Podzielinski, Eugenia Girda, Setsuko K. Chambers, Thomas E. Buekers, Richard A. Boothby, Joel I. Sorosky, John M. McDonald, Barbara M. Buttin, John A. Keech, Shohreh Shahabi, Adam C. Walter, Michael J. Swartz, Jyoti S. Mayadev, Terrence P. Cescon, Jeffrey W. Elder, Elmer G. Lehman, Peter G. Rose, Peter C. Lim, Saketh R. Guntupalli, Charles A. Kunos, Paul Celano, Raanan Alter, Lemuel S. Ariaratnam, Thomas J. Herzog, Michael E. Carney, Dan S. Zuckerman, Yiqing Xu, Katherine M. Moxley, Kian Behbakht, Colleen C. McCormick, Jamie N. Bakkum-Gamez, Daniel C. Kredentser, Frederick R. Ueland, Jondavid Pollock, Parviz Hanjani, Krishnansu S. Tewari, Paul A. DiSilvestro, James L. Wade, Kristin A. Bradley, Augusto C. Ochoa, Omar M. Ragab, Gretchen E. Glaser, Paul D. Aridgides, Robert S. Mannel, Alexander B. Olawaiye, Nicola M. Spirtos, David K. Gaffney, Debra L. Richardson, Yovanni Casablanca, Sharad A. Ghamande, Albert S. DeNittis, Eric D. Donnelly, James J. Urbanic, Lara Hathout, Andrew C. Hoover, Kerry J. Rodabaugh, Marguerite (Meg) L. Palisoul, William H. Bradley, Harriet Eldredge-Hindy, Gregory A. Masters, Benjamin B. Bridges, David Griffin, Ann M. Morris, Eric Leung
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)
Collaborators: NRG Oncology

This content was sourced from clinicaltrials.gov

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