Feasibility Study of the Combination of Radiotherapy, Chemotherapy and Hyperthermia for the Treatment of Stage IIB-III-IVA 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.
Interventional
Primary Purpose: Treatment
Anneke M. Westermann, MD, PhD
Study Chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
United States: Federal Government
CDR0000068376
NCT00008112
June 2000
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