Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer
Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 6, 2005
Trial Information
Current as of April 26, 2025
Terminated
Keywords
ClinConnect Summary
PRIMARY OBJECTIVE:
I. Compare the progression-free survival of patients with stage IB, IIA, IIB, IIIB, or IVA carcinoma of the cervix treated with cisplatin and radiotherapy with vs without tirapazamine.
SECONDARY OBJECTIVES:
I. Compare overall survival of patients treated with these regimens. II. Compare the toxicity of these regimens in these patients.
TERTIARY OBJECTIVES:
I. Correlate study treatment with tumor expression of carbonic anhydrase IX (CA-IX) and recurrence-free survival, overall survival, or metastasis in patients treated with these regimens.
II. Correlate expression o...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 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
- • Creatinine ≤ ULN or calculated creatinine clearance ≥ 60mL/min
- • No New York Heart Association class III-IV heart failure
- • No history of myocardial infarction
- • No unstable angina
- • No uncontrolled hypertension
- • No pregnant or nursing
- • Negative pregnancy test
- • Fertile patients must use effective contraception
- • No septicemia or severe infection
- • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- • No prior hysterectomy or planned hysterectomy as part of initial cervix cancer therapy
- • No prior coronary artery bypass surgery
- • No prior cancer therapy that would preclude study treatment
- • No concurrent angina medication
- • No concurrent intensity-modulated radiotherapy
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Kansas City, Kansas, United States
New Haven, Connecticut, United States
Durham, North Carolina, United States
Birmingham, Alabama, United States
Cleveland, Ohio, United States
Charleston, South Carolina, United States
Chicago, Illinois, United States
Cleveland, Ohio, United States
Charlottesville, Virginia, United States
Buffalo, New York, United States
Jamaica, New York, United States
New York, New York, United States
Iowa City, Iowa, United States
Abington, Pennsylvania, United States
Tacoma, Washington, United States
South Bend, Indiana, United States
Toms River, New Jersey, United States
Salt Lake City, Utah, United States
New York, New York, United States
Calgary, Alberta, Canada
Sudbury, Ontario, Canada
Regina, Saskatchewan, Canada
Manhasset, New York, United States
Little Rock, Arkansas, United States
Fort Sam Houston, Texas, United States
Bangor, Maine, United States
Anchorage, Alaska, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Oklahoma City, Oklahoma, United States
Des Moines, Iowa, United States
Thunder Bay, Ontario, Canada
Montreal, Quebec, Canada
Great Falls, Montana, United States
Cleveland, Ohio, United States
Allentown, Pennsylvania, United States
New Hyde Park, New York, United States
Phoenix, Arizona, United States
Greeley, Colorado, United States
Loveland, Colorado, United States
Chanute, Kansas, United States
Dodge City, Kansas, United States
Newton, Kansas, United States
Wellington, Kansas, United States
Winfield, Kansas, United States
Traverse City, Michigan, United States
Jackson, Mississippi, United States
Billings, Montana, United States
American Fork, Utah, United States
Logan, Utah, United States
Murray, Utah, United States
Ogden, Utah, United States
Chicago, Illinois, United States
Cincinnati, Ohio, United States
Duarte, California, United States
Stanford, California, United States
Houston, Texas, United States
Elkhart, Indiana, United States
Indianapolis, Indiana, United States
Lewes, Delaware, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Normal, Illinois, United States
Bismarck, North Dakota, United States
Nashville, Tennessee, United States
Laredo, Texas, United States
Salina, Kansas, United States
Canton, Illinois, United States
Urbana, Illinois, United States
Shakopee, Minnesota, United States
Mobile, Alabama, United States
Pomona, California, United States
Wilson, North Carolina, United States
Dayton, Ohio, United States
Anthony, Kansas, United States
Fort Scott, Kansas, United States
Independence, Kansas, United States
Lawrence, Kansas, United States
Lancaster, Pennsylvania, United States
Cincinnati, Ohio, United States
Elkton, Maryland, United States
Washington, District Of Columbia, United States
Honolulu, Hawaii, United States
Columbus, Ohio, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Milwaukee, Wisconsin, United States
Phoenix, Arizona, United States
Jacksonville, Florida, United States
Chicago, Illinois, United States
South Bend, Indiana, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Columbia, Missouri, United States
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Omaha, Nebraska, United States
New Brunswick, New Jersey, United States
Syracuse, New York, United States
Winston Salem, North Carolina, United States
Bismarck, North Dakota, United States
Amarillo, Texas, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Seattle, Washington, United States
Hartford, Connecticut, United States
New Britain, Connecticut, United States
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Aurora, Illinois, United States
Joliet, Illinois, United States
Michigan City, Indiana, United States
Camden, New Jersey, United States
Neptune, New Jersey, United States
Brooklyn, New York, United States
Canton, Ohio, United States
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Columbus, Ohio, United States
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Mayfield Heights, Ohio, United States
Mentor, Ohio, United States
Nashville, Tennessee, United States
Providence, Rhode Island, United States
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Wyoming, Michigan, United States
Castro Valley, California, United States
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Park Ridge, Illinois, United States
Ames, Iowa, United States
Grand Rapids, Michigan, United States
Springfield, Missouri, United States
Salem, Oregon, United States
Tacoma, Washington, United States
Green Bay, Wisconsin, United States
Vancouver, British Columbia, Canada
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Honolulu, Hawaii, United States
Atlanta, Georgia, United States
Louisville, Kentucky, United States
Bethlehem, Pennsylvania, United States
Royal Oak, Michigan, United States
Stony Brook, New York, United States
Honolulu, Hawaii, United States
Indianapolis, Indiana, United States
Worcester, Massachusetts, United States
Saint Louis, Missouri, United States
Decatur, Georgia, United States
Bismarck, North Dakota, United States
Bloomington, Illinois, United States
Normal, Illinois, United States
Peoria, Illinois, United States
Peoria, Illinois, United States
Spring Valley, Illinois, United States
El Dorado, Kansas, United States
Kingman, Kansas, United States
Overland Park, Kansas, United States
Parsons, Kansas, United States
Pratt, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Independence, Missouri, United States
Kansas City, Missouri, United States
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Billings, Montana, United States
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Great Falls, Montana, United States
Manhasset, New York, United States
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Pittsburgh, Pennsylvania, United States
Galesburg, Illinois, United States
Urbana, Illinois, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Sioux City, Iowa, United States
Bismarck, North Dakota, United States
Lubbock, Texas, United States
Akron, Ohio, United States
Marietta, Georgia, United States
Peru, Illinois, United States
Des Moines, Iowa, United States
Savannah, Georgia, United States
Tulsa, Oklahoma, United States
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West Islip, New York, United States
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Fayetteville, Arkansas, United States
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Sylmar, California, United States
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Fort Myers, Florida, United States
Columbus, Georgia, United States
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Honolulu, Hawaii, United States
Evanston, Illinois, United States
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La Porte, Indiana, United States
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Battle Creek, Michigan, United States
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Springfield, Missouri, United States
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Brightwaters, New York, United States
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West Reading, Pennsylvania, United States
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Marinette, Wisconsin, United States
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Dayton, Ohio, United States
Tacoma, Washington, United States
Tacoma, Washington, United States
Green Bay, Wisconsin, United States
Oconto Falls, Wisconsin, United States
Surrey, British Columbia, Canada
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Orlando, Florida, United States
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Springfield, Illinois, United States
Escanaba, Michigan, United States
Southfield, Michigan, United States
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
Kearney, Nebraska, United States
Mount Holly, New Jersey, United States
Voorhees, New Jersey, United States
Middletown, New York, United States
Wilmington, North Carolina, United States
Wright Patterson Air Force Base, Ohio, United States
Norton, Virginia, United States
Puyallup, Washington, United States
Wheeling, West Virginia, United States
Orange, California, United States
Mishawaka, Indiana, United States
Pittsburgh, Pennsylvania, United States
Chattanooga, Tennessee, United States
Newark, New Jersey, United States
Richmond, Virginia, United States
Los Angeles, California, United States
Oakland, California, United States
Augusta, Georgia, United States
Honolulu, Hawaii, United States
Shreveport, Louisiana, United States
Bronx, New York, United States
Galveston, Texas, United States
Provo, Utah, United States
Burlington, Vermont, United States
Quebec City, Quebec, Canada
Patients applied
Trial Officials
Paul DiSilvestro
Principal Investigator
Gynecologic Oncology Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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