Head and Neck Cancer Clinical Trial
— IRESSA&H&NOfficial title:
Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial
Verified date | September 2010 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Written informed consent - Age over 18 years - Histologically proven squamous cell cancer of the head & neck (SCCHN) - Indication for postoperative Radiotherapy: pT3, pT4, pN2b, pN2c, pN3 Exclusion Criteria: - Hypersensitivity to ZD1839 or any of the excipients of this product - Tumour stage M1 - Co-existing malignancies diagnosed within the last 5 years. Exceptions: basal cell carcinoma, cervical cancer in situ - Absolute neutrophil counts <1.5 x 109 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Research Site | Basel | |
Switzerland | Research Site | Bern |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the feasibility and safety of (cohort 1) postoperative standard fractionation radiotherapy plus Iressa and of (cohort 2) hyperfractionated radiotherapy plus cisplatin and Iressa | No | ||
Secondary | Both cohorts overall survival (OS) local control (LC) rate at six months and at one year | No | ||
Secondary | Cohort 1 only time-to-recurrence (TTR) | No | ||
Secondary | Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF) | No |
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