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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. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180934
First Posted: September 16, 2005
Last Update Posted: December 23, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180934


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

ClinicalTrials.gov Identifier: NCT00180934     History of Changes
Other Study ID Numbers: JANORL
CSET 98/656
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: December 23, 2005
Last Verified: September 2005

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