Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix
Launched by GYNECOLOGIC ONCOLOGY GROUP · Feb 5, 2003
Trial Information
Current as of May 27, 2025
Terminated
Keywords
ClinConnect Summary
OBJECTIVES:
* Compare progression-free survival and survival of patients with stage IB2 carcinoma of the cervix after radical hysterectomy with tailored chemoradiotherapy vs primary chemoradiotherapy.
* Compare the toxicity of these regimens in these patients.
* Compare the health-related quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: (Surgery followed by chemoradiotherapy): Patients undergo exploratory laparotomy followed by radical hysterectomy and bilateral pelvic and...
Gender
FEMALE
Eligibility criteria
- DISEASE CHARACTERISTICS:
- * Histologically confirmed stage IB2 invasive carcinoma of the uterine cervix of one of the following types:
- • Squamous cell carcinoma
- • Adenocarcinoma
- • Adenosquamous carcinoma
- • Primary, previously untreated disease
- • Exophytic cervical lesions greater than 4 cm in diameter OR
- • Cervical expansion to greater than 4 cm in diameter, presumed to be the result of principal involvement with cancer
- • No evidence of extrauterine disease other than pelvic lymph node involvement (by clinical and radiographic examinations)
- • No para-aortic lymph nodal disease (suspected on CT scan, MRI, positron-emission tomography, or lymphangiogram) unless nodes are confirmed to be pathologically negative (by CT-guided biopsy or extraperitoneal lymph node dissection)
- • Eligible for radical hysterectomy and lymph node dissection
- PATIENT CHARACTERISTICS:
- • Age
- • 18 and over
- • Performance status
- • GOG 0-2
- • Life expectancy
- • Not specified
- • Hematopoietic
- • Absolute neutrophil count at least 1,500/mm\^3
- • Platelet count at least 100,000/mm\^3
- • Hepatic
- • Bilirubin no greater than 1.5 times normal
- • SGOT no greater than 3 times normal
- • Alkaline phosphatase no greater than 3 times normal
- • Renal
- • Creatinine no greater than 2.0 mg/dL
- • No renal abnormalities requiring modification of radiation fields
- • Gastrointestinal
- • No gastrointestinal bleeding
- • No intestinal obstruction
- • Other
- • Not pregnant
- • Negative pregnancy test
- • No septicemia or severe infection
- • No other invasive malignancy with any evidence of disease within the past 5 years except nonmelanoma skin cancer
- • No circumstances that would preclude study completion or required follow-up
- PRIOR CONCURRENT THERAPY:
- • Biologic therapy
- • Not specified
- • Chemotherapy
- • No prior chemotherapy
- • Endocrine therapy
- • Not specified
- • Radiotherapy
- • No prior radiotherapy
- • Surgery
- • See Disease Characteristics
- • No prior hysterectomy (total or subtotal)
About Gynecologic Oncology Group
The Gynecologic Oncology Group (GOG) is a leading clinical trial sponsor dedicated to advancing the understanding and treatment of gynecologic cancers. Comprising a network of experts in the field, GOG conducts rigorous, multi-institutional research to evaluate innovative therapeutic strategies and improve patient outcomes. Through its commitment to high-quality clinical trials, the organization aims to enhance the standard of care for women diagnosed with gynecologic malignancies, fostering collaborations with academic institutions and industry partners to translate scientific discoveries into effective treatments. GOG's mission emphasizes patient safety, ethical research practices, and the dissemination of findings to benefit the broader medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Houston, Texas, United States
Los Angeles, California, United States
Washington, District Of Columbia, United States
Chicago, Illinois, United States
Durham, North Carolina, United States
Abington, Pennsylvania, United States
Kansas City, Missouri, United States
Urbana, Illinois, United States
Kalamazoo, Michigan, United States
Saint Louis Park, Minnesota, United States
Ann Arbor, Michigan, United States
Hershey, Pennsylvania, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Columbus, Ohio, United States
Madison, Wisconsin, United States
Orange, California, United States
Newark, Delaware, United States
Evanston, Illinois, United States
South Bend, Indiana, United States
Grand Rapids, Michigan, United States
Columbia, Missouri, United States
Omaha, Nebraska, United States
Portland, Oregon, United States
Danville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Knoxville, Tennessee, United States
Temple, Texas, United States
Chicago, Illinois, United States
Decatur, Illinois, United States
Galveston, Texas, United States
Camden, New Jersey, United States
Phoenix, Arizona, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Burlington, Vermont, United States
Stony Brook, New York, United States
Philadelphia, Pennsylvania, United States
Bethesda, Maryland, United States
Springfield, Missouri, United States
Pittsburgh, Pennsylvania, United States
Birmingham, Alabama, United States
Iowa City, Iowa, United States
New Haven, Connecticut, United States
Cincinnati, Ohio, United States
Nashville, Tennessee, United States
Los Gatos, California, United States
Jackson, Mississippi, United States
Kagoshima City, , Japan
Patients applied
Trial Officials
D. Scott McMeekin, MD
Study Chair
Oklahoma University Cancer Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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