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Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer That Has Been Removed During Surgery

NCT00002670 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2014-01-24

No results posted yet for this study

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy plus cisplatin is more effective than radiation therapy alone in treating patients with head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin with radiation therapy alone in treating patients with head and neck cancer that has been removed during surgery.

Conditions

Interventions

DRUG

chemotherapy

DRUG

cisplatin

RADIATION

low-LET cobalt-60 gamma ray therapy

RADIATION

low-LET electron therapy

RADIATION

low-LET photon therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • SWOG Cancer Research Network

    collaborator NETWORK

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Jay S. Cooper, MD, FACR, FACRO · NYU Langone Health

  • James N. Endicott, MD, PA · H. Lee Moffitt Cancer Center and Research Institute

  • Julie A. Kish, MD, FACP · Josephine Ford Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-09-30
Primary Completion
2002-07-31
Completion
2013-11-30

Countries

  • United States
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00002670 on ClinicalTrials.gov