High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer

NCT00002555 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2012-07-02

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 if radiation therapy plus chemotherapy 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 high-dose radiation therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head and neck cancer who have undergone surgery to remove the cancer.

Conditions

Interventions

DRUG

cisplatin

RADIATION

low-LET cobalt-60 gamma ray therapy

RADIATION

low-LET electron therapy

RADIATION

low-LET photon therapy

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Jacques Bernier, MD, PhD · Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-02-28
Primary Completion
2000-10-31

Countries

  • Belgium
  • France
  • Italy
  • Netherlands
  • Poland
  • Slovenia
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

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 NCT00002555 on ClinicalTrials.gov