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

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ClinicalTrials.gov Identifier: NCT00180934
Recruitment Status : Unknown
Verified September 2005 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : December 23, 2005
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Recurrence of Head and Cancer in Irraiated Area Procedure: Reirradiation with concomitant chemotherapy Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 280 participants
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
Study Start Date : July 1999

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U.S. FDA Resources




Primary Outcome Measures :
  1. Overall survival at 3 years

Secondary Outcome Measures :
  1. Local event-free survival
  2. Toxicity


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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:


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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

ClinicalTrials.gov Identifier: NCT00180934     History of Changes
Other Study ID Numbers: JANORL
CSET 98/656
First Posted: September 16, 2005    Key Record Dates
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