Back to resultsReirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area
Primary Purpose
Recurrence of Head and Cancer in Irraiated Area
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Reirradiation with concomitant chemotherapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Recurrence of Head and Cancer in Irraiated Area
Eligibility 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: -
Sites / Locations
- Institut Gustave Roussy
Outcomes
Primary Outcome Measures
Overall survival at 3 years
Secondary Outcome Measures
Local event-free survival
Toxicity
Full Information
NCT ID
NCT00180934
First Posted
September 13, 2005
Last Updated
December 22, 2005
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT00180934
Brief Title
Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area
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 Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrence of Head and Cancer in Irraiated Area
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Reirradiation with concomitant chemotherapy
Primary Outcome Measure Information:
Title
Overall survival at 3 years
Secondary Outcome Measure Information:
Title
Local event-free survival
Title
Toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François JANOT, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
12. IPD Sharing Statement
Learn more about this trial
Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area
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