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Perioperative versus adjuvant chemotherapy for pancreatic cancer


Title A phase III trial of perioperative versus adjuvant chemotherapy for resectable pancreatic cancer
Therapeutic Area Pancreatic Cancer
Principal Investigator Jakob Elkon, MD
Min Age 18 Years
Gender All
Contact ssexton@tuftsmedicalcenter.org
617-636-5558
ssexton@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04340141

Overview

The purpose of this study is to compare the usual treatment approach (surgery followed by chemotherapy) to using chemotherapy followed by surgery and then more chemotherapy

Study Details

Inclusion Criteria

  • Age ≥ 18 years
  • Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at IROC Ohio.
  • Determined to be appropriate candidate for curative-intent pancreatectomy

Exclusion Criteria

  • Prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer.
  • Pregnant or nursing
  • Comorbid conditions that would prohibit curative-intent pancreatectomy

Study Requirements

This study has 2 study groups. You will be told which group you are in.

  1. Group 1: Subjects will get the usual four-drug regimen used to treat this type of cancer, FOLFIRINOX on the first and second day of each 14-day cycle. Subjects will get this drug regimen for 8 cycles, then have the usual surgery to remove the pancreatic cancer, and then get the usual drug regimen for 4 more cycles.
  2. Group 2: Subjects will get the usual four-drug regimen used to treat this type of cancer, FOLFIRINOX on the first and second day of each 14-day cycle. Subjects will then have the usual surgery to remove the pancreatic cancer, then get the usual drug regimen for 12 cycles.