drugset / Trial / NCT00766636
Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary Objective: To assess margin positive resection rate (R1 resection rate; defined as "tumor within 2 mm of surgical margin on final pathology report") in patients treated with preoperative chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy followed by pancreaticoduodenectomy for adenocarcinoma of the pancreatic head. Secondary Objectives: * To assess disease free survival * To assess overall survival * To assess patterns of local and distant failure
Timeline
- Start
- 2008-09
- Primary completion
- 2012-11
- Completion
- —
Outcome
Outcome not reported
Stopped (Enrollment): “Slow Accrual”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 100 mg | Oral |
| Subject | Gemcitabine | Small molecule | 400 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |