Cisplatin Combined With Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with radiation therapy and chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of cisplatin combined with radiation therapy and hyperthermia in treating patients who have stage II, stage III, or stage IV cervical cancer.

Detailed Description
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OBJECTIVES: Determine the feasibility of adding cisplatin and locoregional hyperthermia to external beam and intracavity radiotherapy in patients with stage IIB-IVA cervical cancer. Determine the acute toxicity of this regimen in these patients. Determine the complete response rate of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients undergo external beam radiotherapy (EBRT) once daily 5 days a week for 5 weeks. On 1 day of each week, patients also receive cisplatin IV over 3 hours and hyperthermia over 90 minutes beginning 1-6 hours after completion of EBRT. During week 6, patients receive hyperthermia and cisplatin on the day before the 1 day of intracavity radiotherapy. Treatment continues in the absence of unacceptable toxicity. Patients are followed at 6-8 weeks, every 3 months for 3 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 6-34 patients will be accrued for this study.

Official Title
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Feasibility Study of the Combination of Radiotherapy, Chemotherapy and Hyperthermia for the Treatment of Stage IIB-III-IVA Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: cisplatin
* Procedure: hyperthermia treatment
* Radiation: brachytherapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIB-IVA carcinoma of the cervix Adenocarcinoma Squamous cell carcinoma Mixed cell histology No small cell anaplastic histology No para-aortic lymph node involvement No indication for para-aortic radiotherapy No distant metastases No CNS disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 7.0 mmol/L (approximately 11 g/dL) Epoetin alfa and/or transfusion allowed Hepatic: Not specified Renal: Glomerular filtration rate at least 60 mL/min Cardiovascular: No myocardial infarction within the past 6 months No unstable angina No congestive heart failure with expected inability to tolerate fluid load No cerebrovascular accident within the past 6 months Other: No pacemaker and/or metal implants No active uncontrolled infection No compromised immune status No psychosis No other prior malignancy except nonmelanoma skin cancer No mental or other physical inability that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy Surgery: No prior surgery

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Procedure: hyperthermia treatment|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, stage III cervical cancer, stage IIB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma, cervical adenosquamous cell carcinoma