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A021806


Title A021806, 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 Both
Contact NCCCR Staff
617-636-3264
NCCCR@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04340141?term=NCT04340141&draw=1&rank=1

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

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

Exclusion Criteria

1. Prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer.
2. Pregnant or nursing
3. 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: Sujects 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. Sujects 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.