Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer

Study Overview
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Brief Summary
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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

Official Title
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Conventional Postoperative Radiotherapy (Standard Fractionation) Plus Iressa or Hyperfractionated Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer: A Phase I Pilot Trial

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Gefitinib
* Drug: Gefitinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>post operative combination of gefinib and RT | Drug: Gefitinib<br>* 250 mg; oral<br>* Other names: IRESSA (TM);|
| Experimental: Cohort 2<br>combination of gefitinib with RT and Chemotherapy in non operated patients | Drug: Gefitinib<br>* 250mg; oral<br>* Other names: IRESSA (TM);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Both cohorts overall survival (OS) local control (LC) rate at six months and at one year |  |  | 
| Cohort 1 only time-to-recurrence (TTR) |  |  | 
| Cohort 2 only time-to-progression (TTP). Complete Response (CR) rate time to treatment failure (TTF) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)