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Brief Title: Effect of Iressa With/Without Concurrent Chemoradiotherapy on Tumor Gene Expression Profiles in Patients With Advanced Non-Nasopharyngeal Head and Neck Carcinoma
Official Title: Phase II Study of Iressa With/Without Concurrent Chemoradiotherapy in Patients With Advanced Non-Nasopharyngeal Head and Neck Carcinoma and to Study the Effect of Iressa™ (ZD1839) on Tumour Gene Expression Profiles ®
Study ID: NCT00228488
Brief Summary: Two different patient populations will be targeted for this study. The first population (SP1) will include patients with recurrent/metastatic head and neck cancers, excluding salivary gland carcinomas. The second population (SP2) will include treatment-naïve patients with locally advanced squamous cell head and neck cancer (SCHNC). SP1 will be treated with palliative intent and the patients can be treatment-naïve or have received prior chemotherapy. Study treatment will consist of Iressa (gefitinib) alone. SP2 will be treated with radical intent. The patients must be treatment-naïve and study treatment will consist of induction Iressa for 3 weeks followed by a combination of Iressa plus cisplatin and concurrent irradiation.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Hong Kong, , Hong Kong
, Singapore, , Singapore
Name: AstraZeneca Medical Department
Affiliation: AstraZeneca
Role: STUDY_DIRECTOR