Treatment of Patients With Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Gynecologic Oncology Group
- Locations
- 50
Study Overview
Brief 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.
Detailed Description
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.
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Arm I: (Surgery followed by chemoradiotherapy): Patients undergo exploratory laparotomy followed by radical hysterectomy and bilateral pelvic and para-aortic lymphadenectomy. Depending on the findings at surgery, the radical hysterectomy and lymphadenectomy are either completed or aborted.
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Aborted hysterectomy: Patients with aborted hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times normal
- •SGOT no greater than 3 times normal
- •Alkaline phosphatase no greater than 3 times normal
- •Creatinine no greater than 2.0 mg/dL
- •No renal abnormalities requiring modification of radiation fields
- •Gastrointestinal
- •No gastrointestinal bleeding
- •No intestinal obstruction
- •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
- •See Disease Characteristics
- •No prior hysterectomy (total or subtotal)
Exclusion Criteria
- Not provided