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

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ClinicalTrials.gov Identifier: NCT00169221
Recruitment Status : 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)
First Posted : September 15, 2005
Last Update Posted : November 15, 2011
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou

Brief Summary:
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 or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Iressa (Gefitinib) Radiation: chemoradiotherapy with cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2005
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 3 years ]


Information from the National Library of Medicine

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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:

  • 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)

Information from the National Library of Medicine

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT00169221     History of Changes
Other Study ID Numbers: GORTEC 2004-02
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 15, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Gefitinib
Cisplatin
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action