Status:
COMPLETED
Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00681967
Start Date
February 1 2004
End Date
October 1 2009
Last Update
September 23 2010
Active Locations (2)
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1
Research Site
Basel, Switzerland
2
Research Site
Bern, Switzerland