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

Phase 2

• Conditions: Cervical Cancer

• Registration Number: NCT00008112
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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

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.

Study Timeline

• Study Start: 2000-06
• Study First Submitted: 2001-01-06
• Status Verified: 2002-10
• Study First Submitted QC: 2003-06-04
• Study First Posted: 2003-06-05
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

University Hospital - Rotterdam Dijkzigt; 🇳🇱 Rotterdam, Netherlands

Rotterdam Cancer Institute; 🇳🇱 Rotterdam, Netherlands

Academisch Ziekenhuis Utrecht; 🇳🇱 Utrecht, Netherlands