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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | post operative combination of gefinib and RT |
|
| Cohort 2 | Experimental | combination of gefitinib with RT and Chemotherapy in non operated patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib | Drug | 250 mg; oral |
|
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Rochlitz, Prof Dr med | University Hospital of Basel | Principal Investigator |
| Madeleine Billeter, MD | AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland | Study Director |
| Verena Renggli | AstraZeneca AG, Grafenau 10; 6300 Zug; Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Basel | Switzerland | ||||
| Research Site |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Gefitinib |
| Drug |
250mg; oral |
|
|
| Bern |
| Switzerland |