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

NCT00085631 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2013-09-17

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Northwestern University

    collaborator OTHER

  • Mark Dewhirst

    lead OTHER

Principal Investigators

  • Ellen L. Jones, MD, PhD · Duke Cancer Institute

  • Leonard R. Prosnitz, MD · Duke Cancer Institute

  • Mark Dewhirst, DVM PhD · Duke Cancer Institute

  • Zeljko Vujaskovic, MD PhD · Duke Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2008-11-30
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00085631 on ClinicalTrials.gov