Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

December 22, 2005 updated by: Gustave Roussy, Cancer Campus, Grand Paris

Interest of a Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area: a Multicentric Phase III Randomized Trial

Interest of a reirradiation with concomitant chemotherapy after salvage surgery for recurrence of head and cancer in irradiated area : a multicentric Phase III randomized trial

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villejuif, France, 94800
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • head and neck squamous cancer
  • both sexes
  • >=18 years
  • recurrence treated by surgery and initially treated by radiotherapy
  • with written informed consent at entry time

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival at 3 years

Secondary Outcome Measures

Outcome Measure
Toxicity
Local event-free survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Principal Investigator: François JANOT, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

December 23, 2005

Last Update Submitted That Met QC Criteria

December 22, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JANORL
  • CSET 98/656

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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