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

This study has been terminated.
(Toxicity in an independent study IMEX. The trial was subsequently terminated (54 pts instead of 140) despite safety analyses showing no excess of toxicity)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT00169221
First received: September 12, 2005
Last updated: November 14, 2011
Last verified: November 2011
History of Changes
  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)
Radiation: chemoradiotherapy with cisplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: September 2005
Study Completion Date: July 2011
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: postop chemoradio with cisplatin
postoperative chemoradiotherapy with cisplatin
 Radiation: chemoradiotherapy with cisplatin
postoperative chemoradiotherapy with cisplatin
Experimental: postop chemoradio (cisplatin)+gefitinib
postoperative chemoradiotherapy with cisplatin + gefitinib
 Drug: Iressa (Gefitinib)
postoperative chemoradiotherapy with cisplatin + gefitinib

  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

Locations
France
Centre Antoine Lacassagne
Nice, France, 06189
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
AstraZeneca
Investigators
Principal Investigator: Rene-Jean Bensadoun, MD Centre Antoine Lacassagne
  More Information

No publications provided

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT00169221     History of Changes
Other Study ID Numbers: GORTEC 2004-02
Study First Received: September 12, 2005
Last Updated: November 14, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Carcinoma
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Gefitinib
Cisplatin
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013