Conditions: Pancreatic Neoplasms
Keywords: stereotactic radiosurgery borderline resectable pancreatic cancer gastrointestinal pancreas
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 2
Healthy volunteers: no

Brief summary:
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.

Detailed description:
* 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.

Arms:
arm 1: GTX-SRS: Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS)

Interventions: intervention 1: GTX (gemcitabine, docetaxel and capecitabine) intervention 2: stereotactic body radiation therapy
Intervention descriptions: intervention 1: GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14 intervention 2: stereotactic body radiation therapy (SBRT) 25

Protocol document: