Clinical trial NCT00085631
Conditions: Cervical Cancer
Keywords: stage IA cervical cancer stage IB cervical cancer stage IIA cervical cancer stage IIB cervical cancer stage III cervical cancer stage IVA cervical cancer cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma
Sponsor: Mark Dewhirst
Start date: 2003-03-01; Completion date: 2009-06-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Patients received cisplatin IV and concurrently underwent hyperthermia treatment over 60-90 minutes on day 1. Patients also underwent external beam radiation therapy once daily on days 1-5. Treatment repeated weekly for 5-6 weeks in the absence of disease progression or unacceptable toxicity. After completion of chemoradiotherapy and hyperthermia, patients underwent brachytherapy to the cervix for 2-3 days. arm 2: Patients received cisplatin and undergo external beam radiation therapy (and brachytherapy) as in arm I.
Interventions: intervention 1: cisplatin intervention 2: hyperthermia treatment intervention 3: brachytherapy intervention 4: external beam radiation therapy
Intervention descriptions: intervention 1: Given IV intervention 2: Patients undergo hyperthermia treatment over 60-90 minutes intervention 3: Patients undergo brachytherapy for 2-3 days intervention 4: Patients undergo external beam radiation therapy once daily on days 1-5

Protocol documents: