NCT02243007

Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Resectable Pancreatic Cancer
• Pancreatic Ductal Carcinoma

Interventions

Type	Name	Description
DRUG	FOLFIRINOX
DRUG	Gemcitabine/nab-Paclitaxel
RADIATION	Radiation therapy
DRUG	Capecitabine

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-09-17
• Last updated: 2017-05-16
• Results posted: 2017-05-16

Locations

1 site across 1 country: United States