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Sponsors and Collaborators: |
Groupe Oncologie Radiotherapie Tete et Cou AstraZeneca |
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Information provided by: | Groupe Oncologie Radiotherapie Tete et Cou |
ClinicalTrials.gov Identifier: | NCT00169221 |
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 |
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Head and Neck Cancer |
Drug: Iressa (Gefitinib) |
Phase II |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rene-Jean Bensadoun, MD | 33 4 92 03 12 70 | rene-jean.bensadoun@nice.fnclcc.fr |
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 |
Principal Investigator: | Rene-Jean Bensadoun, MD | Centre Antoine Lacassagne |
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 |
Cisplatin Head and Neck Neoplasms Gefitinib Carcinoma |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |