Cervical Cancer Clinical Trial
Official title:
Feasibility Study of the Combination of Radiotherapy, Chemotherapy and Hyperthermia for the Treatment of Stage IIB-III-IVA Cervical Cancer
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.
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.
;
Primary Purpose: Treatment
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