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

This study is ongoing, but not recruiting participants.

Sponsored by:	Institut Gustave Roussy
Information provided by:	Institut Gustave Roussy
ClinicalTrials.gov Identifier:	NCT00180934

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 III

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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

Study ID Numbers:	JANORL, CSET 98/656
Study First Received:	September 13, 2005
Last Updated:	December 22, 2005
ClinicalTrials.gov Identifier:	NCT00180934
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Head and Neck Neoplasms
Recurrence

Additional relevant MeSH terms:

Disease Attributes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009