NCT00262821

Brief Summary

This randomized phase III trial is studying cisplatin, radiation therapy, and tirapazamine to see how well they work compared to cisplatin and radiation therapy in treating patients with cervical cancer. Drugs used in chemotherapy, such as cisplatin and tirapazamine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin and tirapazamine may make tumor cells more sensitive to radiation therapy. It is not yet known whether giving cisplatin together with radiation therapy is more effective with or without tirapazamine in treating cervical cancer.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2006

Typical duration for phase_3

Geographic Reach
2 countries

282 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

July 2, 2017

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

4.5 years

First QC Date

December 6, 2005

Results QC Date

October 9, 2015

Last Update Submit

July 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival - Percentage of Patients Alive and Progression Free

    Patients' progression status based on clinical, radiological or pathological (histological) evidence of disease after study therapy. Progression includes any death without evidence of disease progression. Progression-free Survival (PFS) is defined as time in month from study enrollment to disease progression, death or date of last contact.

    From study entry until first disease progression, death or date of last contact, up to 6 years

Secondary Outcomes (2)

  • Overall Survival

    From study entry to death or last contact, up to 6 years

  • Adverse Events (Grade 3 or Higher) During Treatment Period

    All Adverse Events (AEs) occuring during treatment and up to 30 days after stopping the study treatment are reported

Study Arms (2)

Arm I (cisplatin)

ACTIVE COMPARATOR

Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6).

Drug: cisplatin

Arm II (cisplatin, tirapazamine)

EXPERIMENTAL

Patients receive tirapazamine IV over 2 hours on days 1, 8, 10, 12, 15, 22, 24, 26, and 29 and cisplatin IV over 1 hour on days 1, 15, and 29.

Drug: cisplatinDrug: tirapazamine

Interventions

Given IV

Also known as: CACP, CDDP, CPDD, DDP
Arm I (cisplatin)Arm II (cisplatin, tirapazamine)

Given IV

Also known as: SR 4233, Tirazone, WIN 59075
Arm II (cisplatin, tirapazamine)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix
  • Stage IB2, IIA, IIB, IIIB, or IVA disease
  • Stage IIA tumors must be \> 4 cm
  • Primary, untreated disease
  • Negative, non-suspicious para-aortic nodes by lymphangiogram, CT scan, MRI, or lymphadenectomy
  • Must have been adequately clinically staged
  • Suitable for treatment with radical intent using concurrent chemotherapy and pelvic radiotherapy
  • No disease involvement of the lower third of the vagina regardless of stage (all stage IIIA, IIIB and IVA with lower one-third involvement)
  • No carcinoma of the cervical stump
  • Performance status - GOG 0-3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 3 times ULN
  • Alkaline phosphatase ≤ 3 times ULN
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (282)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Mobile Infirmary Medical Center

Mobile, Alabama, 36607, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

Western Regional CCOP

Phoenix, Arizona, 85006, United States

Location

Highlands Oncology Group PA - Fayetteville

Fayetteville, Arkansas, 72703, United States

Location

Washington Regional Medical Center - Fayetteville

Fayetteville, Arkansas, 72703, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Bay Area Tumor Institute CCOP

Oakland, California, 94609, United States

Location

University of California Medical Center At Irvine-Orange Campus

Orange, California, 92868, United States

Location

Pomona Valley Hospital Medical Center

Pomona, California, 91767, United States

Location

Stanford University Hospitals and Clinics

Stanford, California, 94305, United States

Location

Olive View-University of California Los Angeles Medical Center

Sylmar, California, 91342, United States

Location

Colorado Gynecologic Oncology Group

Aurora, Colorado, 80010, United States

Location

Memorial Hospital Colorado Springs

Colorado Springs, Colorado, 80909, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

McKee Medical Center

Loveland, Colorado, 80539, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Florida Gynecologic Oncology

Fort Myers, Florida, 33905, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

UF Cancer Center at Orlando Health

Orlando, Florida, 32806, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

John B Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Dekalb Medical Center

Decatur, Georgia, 30033, United States

Location

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31403, United States

Location

Hawaii Minority Based CCOP

Honolulu, Hawaii, 96813, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States

Location

University of Hawaii

Honolulu, Hawaii, 96813, United States

Location

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, 96817, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

Location

Maui Memorial Medical Center

Wailuku, Hawaii, 96793, United States

Location

Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States

Location

Rush - Copley Medical Center

Aurora, Illinois, 60504, United States

Location

Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital Association

Canton, Illinois, 61520, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Saint Francis Hospital

Evanston, Illinois, 60202, United States

Location

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

Location

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, 60435, United States

Location

Bromenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center Foundation

Normal, Illinois, 61761, United States

Location

Advocate Lutheran General Hospital.

Park Ridge, Illinois, 60068, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Valley Radiation Oncology

Peru, Illinois, 61354, United States

Location

Saint Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Carle Clinic-Urbana Main

Urbana, Illinois, 61801, United States

Location

Elkhart General Hospital

Elkhart, Indiana, 46515, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

Gynecologic Oncology of Indiana

Indianapolis, Indiana, 46237, United States

Location

Community Howard Regional Health

Kokomo, Indiana, 46904, United States

Location

IU Health La Porte Hospital

La Porte, Indiana, 46350, United States

Location

Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, 46360, United States

Location

Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, 46545-1470, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46628, United States

Location

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, 50010, United States

Location

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, 50325, United States

Location

Mercy Capitol

Des Moines, Iowa, 50307, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Iowa Oncology Research Association CCOP

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309, United States

Location

Medical Oncology and Hematology Associates-Laurel

Des Moines, Iowa, 50314, United States

Location

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Siouxland Hematology Oncology Associates

Sioux City, Iowa, 51101, United States

Location

Hospital District Sixth of Harper County

Anthony, Kansas, 67003, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

Providence Medical Center

Kansas City, Kansas, 66112, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Cancer Center of Kansas-Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Radiation Oncology Practice Corporation Southwest

Overland Park, Kansas, 66210, United States

Location

Cancer Center of Kansas - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates In Womens Health

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas - Main Office

Wichita, Kansas, 67214, United States

Location

Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Wichita CCOP

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

Saint Elizabeth Medical Center South

Edgewood, Kentucky, 41017, United States

Location

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Louisiana State University Health Sciences Center Shreveport

Shreveport, Louisiana, 71130, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Medical Center-Bramhall Campus

Portland, Maine, 04102, United States

Location

Union Hospital of Cecil County

Elkton, Maryland, 21921, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Bronson Battle Creek

Battle Creek, Michigan, 49017, United States

Location

Spectrum Health Big Rapids Hospital

Big Rapids, Michigan, 49307, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Green Bay Oncology - Escanaba

Escanaba, Michigan, 49431, United States

Location

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Mercy Health Saint Mary's

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health-Blodgett Campus

Grand Rapids, Michigan, 49506, United States

Location

Gynecologic Oncology of West Michigan PLLC

Grand Rapids, Michigan, 49546, United States

Location

Green Bay Oncology - Iron Mountain

Iron Mountain, Michigan, 49801, United States

Location

Mercy Health Partners-Hackley Campus

Muskegon, Michigan, 49442, United States

Location

Mercy Health Mercy Campus

Muskegon, Michigan, 49444, United States

Location

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Lakeland Hospital

Saint Joseph, Michigan, 49085, United States

Location

Providence Hospital

Southfield, Michigan, 48075, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of Missouri - Ellis Fischel

Columbia, Missouri, 65212, United States

Location

Centerpoint Medical Center LLC

Independence, Missouri, 64057, United States

Location

Radiation Oncology Practice Corporation South

Kansas City, Missouri, 64114, United States

Location

Radiation Oncology Practice Corporation - North

Kansas City, Missouri, 64154, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Center for Cancer Care and Research

St Louis, Missouri, 63141, United States

Location

Saint John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Montana Cancer Consortium CCOP

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies PC

Billings, Montana, 59102, United States

Location

Billings Clinic

Billings, Montana, 59107-7000, United States

Location

Berdeaux, Donald MD (UIA Investigator)

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Good Samaritan Hospital

Kearney, Nebraska, 68847, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Center of Hope at Renown Medical Center

Reno, Nevada, 89502, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Mountainside Hospital

Montclair, New Jersey, 07042, United States

Location

Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

Mount Holly, New Jersey, 08060, United States

Location

Jersey Shore Medical Center

Neptune City, New Jersey, 07753, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

UMDNJ - New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

Virtua West Jersey Hospital Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Women's Cancer Care Associates LLC

Albany, New York, 12208, United States

Location

Island Gynecologic Oncology

Brightwaters, New York, 11718, United States

Location

State University of New York Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Queens Hospital Center

Jamaica, New York, 11432, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

North Shore-LIJ Health System CCOP

Manhasset, New York, 11030, United States

Location

Orange Regional Medical Center

Middletown, New York, 10940, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

North Shore-LIJ Health System/Center for Advanced Medicine

New Hyde Park, New York, 11040, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center-Weiler Division

The Bronx, New York, 10461, United States

Location

Good Samaritan Hospital Medical Center

West Islip, New York, 11795, United States

Location

Hope Women's Cancer Centers-Asheville

Asheville, North Carolina, 28816, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Bismarck Cancer Center

Bismarck, North Dakota, 58501, United States

Location

Mid Dakota Clinic

Bismarck, North Dakota, 58501, United States

Location

Saint Alexius Medical Center

Bismarck, North Dakota, 58501, United States

Location

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

Location

Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Aultman Health Foundation

Canton, Ohio, 44710, United States

Location

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Mount Carmel Health Center West

Columbus, Ohio, 43222, United States

Location

Good Samaritan Hospital - Dayton

Dayton, Ohio, 45406, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Health Center

Dayton, Ohio, 45415, United States

Location

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States

Location

Lake University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

Wright-Patterson Medical Center

Wright-Patterson Air Force Base, Ohio, 45433-5529, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Care Associates-Midtown

Tulsa, Oklahoma, 74104, United States

Location

Tulsa Cancer Institute

Tulsa, Oklahoma, 74146, United States

Location

Salem Hospital

Salem, Oregon, 97301, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18105, United States

Location

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, 18015, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224-1791, United States

Location

Mercy Hospital

Scranton, Pennsylvania, 18501, United States

Location

Hematology and Oncology Associates of North East Pennsylvania

Scranton, Pennsylvania, 18508, United States

Location

Scranton Hematology Oncology

Scranton, Pennsylvania, 18510, United States

Location

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Black Hills Obstetrics and Gynecology

Rapid City, South Dakota, 57701, United States

Location

Chattanooga Gynecological Oncology

Chattanooga, Tennessee, 37403, United States

Location

Chattanooga's Program in Women's Oncology

Chattanooga, Tennessee, 37403, United States

Location

East Tennessee State University

Johnson City, Tennessee, 37614-0054, United States

Location

Meharry Medical College

Nashville, Tennessee, 37208-3599, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555-0565, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Doctor's Hospital of Laredo

Laredo, Texas, 78041, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

American Fork Hospital

American Fork, Utah, 84003, United States

Location

Logan Regional Hospital

Logan, Utah, 84321, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center

Provo, Utah, 84604-3337, United States

Location

Intermountain Health Care

Salt Lake City, Utah, 84103, United States

Location

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, 84106, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Medical Center Regional Cancer Center

St. George, Utah, 84770, United States

Location

Fletcher Allen Health Care-Medical Center

Burlington, Vermont, 05401, United States

Location

Northern Virginia Pelvic Surgery Associates

Annandale, Virginia, 22003, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Bon Secours Mary Immaculate Hospital

Newport News, Virginia, 23602, United States

Location

Southwest VA Regional Cancer Center

Norton, Virginia, 24273, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Carilion Clinic Gynecological Oncology

Roanoke, Virginia, 24016, United States

Location

Good Samaritan Community Hospital

Puyallup, Washington, 98372, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Northwest CCOP

Tacoma, Washington, 98405, United States

Location

Northwest Medical Specialties PLLC

Tacoma, Washington, 98405, United States

Location

Saint Joseph Medical Center

Tacoma, Washington, 98405, United States

Location

Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

Multicare Health System

Tacoma, Washington, 98415, United States

Location

Wheeling Hospital

Wheeling, West Virginia, 26003, United States

Location

Green Bay Oncology at Saint Vincent Hospital

Green Bay, Wisconsin, 54301-3526, United States

Location

Saint Vincent Hospital

Green Bay, Wisconsin, 54301, United States

Location

Green Bay Oncology Limited at Saint Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

Saint Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Green Bay Oncology - Oconto Falls

Oconto Falls, Wisconsin, 54154, United States

Location

Green Bay Oncology - Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235, United States

Location

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

BCCA-Fraser Valley Cancer Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Thunder Bay Regional Health Science Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

CHUQ - Pavilion Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

  • DiSilvestro PA, Ali S, Craighead PS, Lucci JA, Lee YC, Cohn DE, Spirtos NM, Tewari KS, Muller C, Gajewski WH, Steinhoff MM, Monk BJ. Phase III randomized trial of weekly cisplatin and irradiation versus cisplatin and tirapazamine and irradiation in stages IB2, IIA, IIB, IIIB, and IVA cervical carcinoma limited to the pelvis: a Gynecologic Oncology Group study. J Clin Oncol. 2014 Feb 10;32(5):458-64. doi: 10.1200/JCO.2013.51.4265. Epub 2014 Jan 6.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

CisplatinTirapazamine

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTriazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Premature closure due to lack of study drug leading to small number of subjects analyzed.

Results Point of Contact

Title
Angela M. Kuras, Associate Director of Data Management
Organization
NRG Oncology Statistics and Data Management Center - Buffalo

Study Officials

  • Paul DiSilvestro

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2005

First Posted

December 7, 2005

Study Start

February 1, 2006

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

July 23, 2019

Results First Posted

July 2, 2017

Record last verified: 2019-07

Locations