Last updated on May 2016

A Randomized Phase II Study of Perioperative mFOLFIRINOX versus Gemcitabine/nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma


Brief description of study

A Randomized Phase II Study of Perioperative mFOLFIRINOX versus Gemcitabine/nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma

Detailed Study Description

You are being asked to take part in this study because you have pancreatic cancer that can be removed by surgery. People who are not in a study are usually treated with surgery first and then with chemotherapy drugs approved by the Food and Drug Administration (FDA). Sometimes radiation is also used and your doctor can explain which may be best for you. For patients who receive the usual approach for this cancer, about 20 out of 100 are cancer-free at five years.

The purpose of this study is to compare the effects of two different combinations of FDA-approved chemotherapy drugs. These two combinations are called mFOLFIRINOX (oxaliplatin, irinotecan, and fluorouracil) and gemcitabine plus nab-paclitaxel. These chemotherapy drugs will be given before and after surgery. The addition of these chemotherapy drugs before surgery is a new approach that is being tested in this study. This new approach could prevent your cancer from returning, but it could also cause side-effects. This study will allow the researchers to know if it is a good idea to treat pancreatic cancer with chemotherapy drugs before surgery, and if so, to see which of the two drug combinations is better. To be better, the study approach should increase the number of people alive at 2 years from about 40% with the usual approach to about 58% with the newer approach. There will be about 112 people taking part in this study.

Clinical Study Identifier: TX143641

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Pamela Treas

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA
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