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

Groupe Oncologie Radiotherapie Tete et Cou

Status and phase: Terminated; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: Iressa (Gefitinib); Radiation: chemoradiotherapy with cisplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00169221

GORTEC 2004-02

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

postop chemoradio with cisplatin

Active Comparator group

Description:

postoperative chemoradiotherapy with cisplatin

Treatment:

Radiation: chemoradiotherapy with cisplatin

postop chemoradio (cisplatin)+gefitinib

Experimental group

Description:

postoperative chemoradiotherapy with cisplatin + gefitinib

Treatment:

Drug: Iressa (Gefitinib)