Trial Information
Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Christoph Rochlitz, Prof Dr med
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital of Basel
Authority:
Switzerland: Swissmedic
Study ID:
1839IL/0525
NCT ID:
NCT00681967
Start Date:
February 2004
Completion Date:
October 2009
Related Keywords:
- Head and Neck Cancer
- squamous cell cancer of the head & neck
- Gefitinib
- IRESSA
- EGFR Inhibitor
- EGFR-tyrosine kinase inhibitor
- Subjects with histologically proven squamous cell cancer of the head & neck
- Cohort 1:qualifying for postoperative radiotherapy
- (pT3, pT4, pN2b, pN2c, pN3).
- Cohort 2:qualifying for definite chemoradiotherapy
- (Lateral oropharynx, tonsils: T1N2b-3, T2N1-3, T3any N;
- Base of tongue, vallecula: T1N1-3, T2-4 any N; Oral cavity,
- glottic and supraglottic larynx; Any TN1-3, T3-4 any N;
- Hypopharynx: T1N1-3, T2-4 and N)
- Head and Neck Neoplasms