Clinical Trial Details
EORTC-40084-22084-GITCG-ROG
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A phase II-R and a phase III trial evaluating both *Erlotinib (PH II-R) and chemoradiation (PH III) as adjuvant treatment for patients with resected head of pancreas adenocarcinoma *(PH II-R Erlotinib randomization completed, arm 2 closed to accrual effective 04/02/14)
| Trial Status | Closed to Patient Entry |
|---|---|
| Dates |
Date of activation: 14-May-2013 Date Step1 close: 09-Jun-2015 |
| Data management at EORTC | No |
| Design |
Phase 3 Randomized open label |
| Targeted Sample size | EORTC Groups: 300 - All Groups: 950 |
| Treatment |
Radiotherapy, Drug, Drug Fluorouracil, Capecitabine, Erlotinib, Gemcitabine |
| Study Staff |
Jean-Luc Van Laethem (Study Coordinator) , Hopital Universitaires Erasme, Brussels Marie-Ange Lentz (Data Manager) , EORTC Headquarters, Brussels Murielle Mauer (Statistician) , EORTC Headquarters, Brussels Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Maira Seini (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Sofie Verschueren (Clinical Operations Manager) , EORTC Headquarters, Brussels |
| Type of cancer | Pancreatic |
| Participating groups |
EORTC Gastrointestinal Tract Cancer Group EORTC Radiation Oncology Group Radiation Therapy Oncology Group |
| Recruiting centers |
AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium) AZ Turnhout - Campus Sint Elisabeth (Turnhout, Belgium) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Hopital Universitaires Erasme (Brussels, Belgium) |
| Protocol summary | http://clinicaltrials.gov/study/ |
| NCT number | |
| EudraCT | 2011-000618-20 |
| Financial Support | External Grant |
