Post-Operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas

This study is currently recruiting participants.

Verified by Groupe Oncologie Radiotherapie Tete et Cou, September 2005

Sponsors and Collaborators:	Groupe Oncologie Radiotherapie Tete et Cou AstraZeneca
Information provided by:	Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:	NCT00169221

Purpose

This trial will be an open multicentric randomized phase II study comparing post-operative radiotherapy + cisplatin associated or not with Iressa in upper aerodigestive tract carcinomas.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: Iressa (Gefitinib)	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	CARISSA Trial - Multicenter Randomized Phase II Trial Comparing Post-Operative Radiotherapy and Cisplatin Alone or in Combination With the EGFR Inhibitor ZD 1839 (Iressa) in Upper Aerodigestive Tract Carcinomas

Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:

Estimated Enrollment:

140

Eligibility

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

Criteria

Inclusion Criteria:

Patients with upper aerodigestive tract carcinomas (all sites included) having surgical resection and eligible for post-operative radiation + cisplatin.
Patient having a tumoral biopsy (0.5 - 1 cm3) stored in liquid nitrogen at time of surgical resection (patients with small tumors located in larynx for instance will not be included)
Patients receiving post-operative radiation (>=60 Gy on tumor bed and/or cervical area), associated with cisplatin, 6 weeks after surgery at the latest.

Exclusion Criteria:

previous history of cancer (except skin basal cell carcinoma)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169221

Contacts

Contact: Rene-Jean Bensadoun, MD

33 4 92 03 12 70

rene-jean.bensadoun@nice.fnclcc.fr

Locations

France
Centre Antoine Lacassagne	Recruiting
Nice, France, 06189
Contact: Rene-Jean Bensadoun, MD 33 4 92 03 12 70 rene-jean.bensadoun@nice.fnclcc.fr

Sponsors and Collaborators

Groupe Oncologie Radiotherapie Tete et Cou

AstraZeneca

Investigators

Principal Investigator:

Rene-Jean Bensadoun, MD

Centre Antoine Lacassagne

More Information

Study ID Numbers:	GORTEC 2004-02
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00169221
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Cisplatin
Head and Neck Neoplasms
Gefitinib
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009