Conditions: Adenocarcinoma of Head of Pancreas
Keywords: NEOADJUVANT FOLFIRINOX CHEMOTHERAPY LOCALIZED PANCREATIC HEAD ADENOCARCINOMA RADIATION THERAPY
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

Brief summary:
This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research study is to determine the safety and effectiveness of modified Folfirinox and radiation therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening tests will be done to determine if subjects are eligible for participation in this study. If subjects are eligible to participate and agree to participate they will begin chemotherapy. After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of completing radiation therapy, subjects will have surgery. There will also be post-treatment and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after their initial registration.

Detailed description:

Arms:
arm 1: Neoadjuvant Chemotherapy- Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles for 3 cycles with growth factor support Chemoradiation Surgical Resection

Interventions: intervention 1: Neo-adjuvant Chemotherapy intervention 2: Chemoradiation intervention 3: Surgical Resection
Intervention descriptions: intervention 1: 1. Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles, for three (3) cycles with growth factor support.
2. Restaging # 1. (CT or MRI; use same modality as baseline staging unless otherwise indicated by Study Team)

   1. Progressive Disease (PD) → Off study. Subsequent treatment per patient's primary MD.
   2. Stable Disease (SD) or Tumor Response → Continue to Registration #2 for Chemoradiation. intervention 2: 1. Chemoradiation may be administered at selected approved CTN sites.
2. Determination of resectability as reviewed and documented by MUSC-HCC GI Tumor Board.

   1. Unresectable → Off study. Subsequent treatment per patient's primary MD.
   2. Resectable → Continue to Registration #3 for Surgical Resection intervention 3: 1. Meets criteria for resectable\* →pancreaticoduodenectomy (POD)
2. At time of resection, snap frozen tumor specimen sent for correlative biomarker studies

Protocol document: