Pancreatic Neoplasms Clinical Trial
Official title:
A Phase 2 Study of GTX-SRS: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery for Borderline Resectable Pancreatic Cancer
The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at the patient's tumor followed by more chemotherapy can increase the chances that the patient's pancreatic tumor can be removed completely.
- Cycle 1 and 2:
- Days 4, 11 and 25, 32 ....gemcitabine 750 mg/m^2 intravenous piggy back (IVPB) over
30 min
- Days 4, 11 and 25, 32 ....docetaxel 30 mg/m^2 IVPB over 1 hour
- Days 1-14 and 22-35 ....capecitabine 750 mg/m^2 oral twice daily
- Each cycle is 21 days long
- SRS: Day 43 ....25 Gy single fraction to the pancreatic tumor gross target volume
- Cycle 3 and 4:
- Days 54, 61 and 75, 82 ....gemcitabine 750 mg/m^2 IVPB over 30 min
- Days 54, 61 and 75, 82 ....docetaxel 30 mg/m^2 IVPB over 1 hour
- Days 51-64 ....capecitabine 750 mg/m^2 oral twice daily
- Each cycle is 21 days long
- Surgery: Exploratory laparotomy or laparoscopy followed by pancreaticoduodenectomy or
central pancreatectomy with or without vein resection and reconstruction as appropriate.
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