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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Institut Gustave Roussy.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00180934
First received: September 13, 2005
Last updated: December 22, 2005
Last verified: September 2005
History of Changes
  Purpose

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


Condition Intervention Phase
Recurrence of Head and Cancer in Irraiated Area
 Procedure: Reirradiation with concomitant chemotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • Overall survival at 3 years

Secondary Outcome Measures:
  • Local event-free survival
  • Toxicity

Estimated Enrollment: 280
Study Start Date: July 1999
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180934

Locations
France
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: François JANOT, MD Institut Gustave Roussy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180934     History of Changes
Other Study ID Numbers: JANORL, CSET 98/656
Study First Received: September 13, 2005
Last Updated: December 22, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Head and Neck Neoplasms
Recurrence
Neoplasms by Site
 Neoplasms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013