This study is currently not recruiting participants.

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

Investigating Chemotherapy Combinations for Resectable Pancreatic Cancer

Not Recruiting
18 years - 75 years
All
Phase N/A

Brief description of study.

This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients with pancreatic cancer that can be removed by surgery.

Detailed description of study

The purpose of this study is to assess 2-year overall survival in each treatment arm (fluorouracil, irinotecan hydrochloride, and oxaliplatin [modified (m)FOLFIRINOX] and gemcitabine [gemcitabine hydrochloride]/nab-paclitaxel [paclitaxel albumin-stabilized nanoparticle formulation]) in patients with resectable pancreatic cancer; and if the stated threshold is met in one or both arms: to choose the better regimen with respect to 2-year overall survival.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: pancreatic cancer
  • Age: 18 years - 75 years
  • Gender: All

This study investigates the effectiveness of two chemotherapy combinations for treating pancreatic cancer that can be removed by surgery. The purpose of this study is to compare the overall survival rates over two years for patients receiving either a combination of fluorouracil, irinotecan hydrochloride, and oxaliplatin (known as modified FOLFIRINOX) or a combination of gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation.

Participants will be randomly assigned to one of the two study arms. They will receive the assigned chemotherapy treatment before surgery. The study will compare the survival outcomes of the two groups to determine which regimen is more effective over a two-year period.

  • Who can participate: This study is for individuals diagnosed with pancreatic cancer that can be surgically removed. Participants must meet specific medical criteria to be eligible.
  • Study details: Participants will be randomly assigned to receive one of two chemotherapy regimens before surgery. These regimens include either modified FOLFIRINOX, which is a variation of the standard FOLFIRINOX regimen with adjusted dosages for better tolerance, or gemcitabine with paclitaxel albumin-stabilized nanoparticles.
  • Study Timelines: The study will last 2 years.
Updated on 19 Feb 2024. Study ID: 1710831892 (S1505)

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