A Phase 2 Study of GTX-SRS: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery for Borderline Resectable Pancreatic Cancer
- 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Resectability
The intent was to have 33 Evaluable Participants and measure the number of surgical resections with negative margins, ie. R0 resection rate. The new treatment would be of interest if the resectability rate was at least 30%. R0 resections were to be scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin were negative for tumor involvement.
6 months per patient
No
Gregory Springett, M.D., Ph.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
MCC-15587
NCT00833859
March 2009
March 2010
Name | Location |
---|---|
H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |