NCT00085631

Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer

An International Multi Center Phase III Study of Chemoradiotherapy Versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Mark Dewhirst · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in 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. It is not yet known whether chemotherapy and radiation therapy are more effective with or without hyperthermia therapy in treating cervical cancer. PURPOSE: This randomized phase III trial compared the safety and efficacy of cisplatin and radiation therapy, together with hyperthermia therapy versus cisplatin and radiation therapy alone in the treatment of locally advanced cervical cancer.

Detailed description

OBJECTIVES: Compare local control, failure-free survival, and overall survival of patients with locally advanced carcinoma of the cervix treated with cisplatin and radiotherapy alone, versus cisplatin and radiotherapy with hyperthermia . OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease stage (IIB or IIIA vs IIIB or IVA) and age (\< 60 years vs ≥ 60 years). Patients are randomized to 1 of 2 treatment arms. LIMITATIONS: There are integrity issues with the currently available data, involving international institutions, in that several pieces of information relating to patient accrual and outcomes cannot be verified. Therefore, it would be inappropriate to report outcome measures for this study. Baseline measures of age and gender are reported for the entire study cohort. Participant flow is reported by treatment arm assignment, which was available for a majority of patients in the currently available data. Adverse events are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	Given IV
PROCEDURE	hyperthermia treatment	Patients undergo hyperthermia treatment over 60-90 minutes
RADIATION	brachytherapy	Patients undergo brachytherapy for 2-3 days
RADIATION	external beam radiation therapy	Patients undergo external beam radiation therapy once daily on days 1-5

Timeline

• Start date: 2003-03-01
• Primary completion: 2008-11-01
• Completion: 2009-06-01
• First posted: 2004-06-11
• Last updated: 2013-09-17
• Results posted: 2013-09-17

Locations

1 site across 1 country: United States