Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of radiation therapy combined with chemotherapy, with or without surgery, is more effective in treating early cancer of the cervix.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery followed by different regimens of radiation therapy and chemotherapy with that of chemotherapy and radiation therapy alone in treating patients who have stage I cancer of the cervix.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin

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)