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Toxicity in an independent study IMEX. The trial was subsequently terminated (54 pts instead of 140) despite safety analyses showing no excess of toxicity
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
This trial will be an open multicentric randomized phase II study comparing post-operative radiotherapy + cisplatin associated or not with Iressa in upper aerodigestive tract carcinomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| postop chemoradio with cisplatin | Active Comparator | postoperative chemoradiotherapy with cisplatin |
|
| postop chemoradio (cisplatin)+gefitinib | Experimental | postoperative chemoradiotherapy with cisplatin + gefitinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iressa (Gefitinib) | Drug | postoperative chemoradiotherapy with cisplatin + gefitinib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rene-Jean Bensadoun, MD | Centre Antoine Lacassagne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Antoine Lacassagne | Nice | 06189 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22855581 | Derived | Thariat J, Bensadoun RJ, Etienne-Grimaldi MC, Grall D, Penault-Llorca F, Dassonville O, Bertucci F, Cayre A, De Raucourt D, Geoffrois L, Finetti P, Giraud P, Racadot S, Moriniere S, Sudaka A, Van Obberghen-Schilling E, Milano G. Contrasted outcomes to gefitinib on tumoral IGF1R expression in head and neck cancer patients receiving postoperative chemoradiation (GORTEC trial 2004-02). Clin Cancer Res. 2012 Sep 15;18(18):5123-33. doi: 10.1158/1078-0432.CCR-12-1518. Epub 2012 Aug 1. |
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| chemoradiotherapy with cisplatin | Radiation | postoperative chemoradiotherapy with cisplatin |
|
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| D059248 | Chemoradiotherapy |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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