Conditions: Resectable Pancreatic Cancer Pancreatic Ductal Carcinoma
Keywords: Resectable pancreatic cancer Pancreatic Ductal Carcinoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7
Healthy volunteers: no

Brief summary:
This research study is a Phase II clinical trial, which evaluates a combination of drugs, FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery.

Detailed description:
Patients who fulfill eligibility criteria will be randomized to Arm A or Arm B

* Treatment will be administered on an outpatient basis.
* Upon registration participants will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
* After completion of FOLFIRINOX or Gemcitabine/Nab-paclitaxel, all participants without progressive disease will proceed to radiation therapy with capecitabine .
* Between 2 and 4 weeks after radiation is complete, participants will proceed for surgical resection of pancreatic cancer

Arms:
arm 1: Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

* Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
* After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
* Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer arm 2: * Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
* Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
* After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
* Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Interventions: intervention 1: FOLFIRINOX intervention 2: Gemcitabine/nab-Paclitaxel intervention 3: Radiation therapy intervention 4: Capecitabine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: