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

Study Overview
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Brief Summary
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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
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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 para-aortic lymphadenectomy. Depending on the findings at surgery, the radical hysterectomy and lymphadenectomy are either completed or aborted. Aborted hysterectomy: Patients with aborted hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery. Group 1: Within 4 weeks of surgery, patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavitary irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 5-6 doses. Group 2: Patients receive radiotherapy and cisplatin as in group 1 with additional extended field radiotherapy. Group 3: Patients receive further treatment at the discretion of the investigator. Completed hysterectomy: Patients completing the radical hysterectomy are assigned to 1 of 3 groups, depending on the findings at surgery. Group A: Patients receive treatment as in group 1 above without intracavity irradiation. Group B: Patients receive treatment as in group 2 above without intracavity irradiation. Group C: Patients receive no further treatment. Arm II (Primary chemoradiotherapy): Patients undergo pelvic radiotherapy 5 times weekly for 4-6 weeks and intracavity irradiation during or after external radiotherapy. Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 6 doses. Quality of life is assessed at baseline, during week 5 of therapy, and then at 3, 6, and 12 months. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 740 patients (370 per treatment arm) will be accrued for this study within 7.5 years.

Official Title
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Treatment of Patients With Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: cisplatin
* Procedure: adjuvant therapy
* Procedure: conventional surgery
* Radiation: brachytherapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Procedure: adjuvant therapy|nan|
|Procedure: conventional surgery|nan|
|Radiation: brachytherapy|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IB cervical cancer