Preoperative mFOLFIRINOX or Gemcitabine-Nab-Paclitaxel Chemotherapy With or Without High-Dose Stereotactic Body Radiation Therapy for Borderline Resectable Pancreatic Adenocarcinoma A Randomized Phase II Study

What this Trial Is About

Researchers are evaluating the addition of isotoxic high-dose stereotactic body radiotherapy iHD-SBRT to preoperative chemotherapy regimens for patients with borderline resectable pancreatic adenocarcinoma. The study focuses on improving surgical outcomes and survival by exploring whether combining radiation therapy with chemotherapy before surgery offers benefits compared to chemotherapy alone. This randomized Phase II trial addresses the uncertainty about the best treatment sequence for this type of pancreatic cancer. Participants first receive 4 cycles of chemotherapy with either mFOLFIRINOX or Gemcitabine plus Nab-Paclitaxel, depending on tolerance. After restaging to assess disease status, those without progression are randomly assigned to one of two groups Arm A continues with 4 more cycles of chemotherapy followed by surgery, while Arm B receives 1 to 2 additional chemotherapy cycles plus iHD-SBRT radiation therapy before surgery. After surgery, adjuvant chemotherapy is given unless the patients condition prevents it. Throughout the study, patients undergo clinical and imaging assessments, including vascular evaluations and biomarker measurements like CA 19.9, to monitor disease status. The main outcomes measured include disease-free survival up to about two years and the rate of complete tumor removal R0 resection within one year. Secondary assessments cover overall survival, response to treatment, complications, side effects, and quality of life over periods extending up to five years. The trial monitors treatment feasibility and safety, with follow-up for both short- and long-term effects.

Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma