Feasibility Study of Preoperative Chemotherapy and Proton Radiotherapy Followed by Surgery for Borderline Resectable Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the feasibility of a combined treatment approach for patients with borderline resectable pancreatic cancer. This interventional, single-arm, open-label trial aims to test referral and enrollment procedures as well as the technical feasibility of delivering preoperative chemotherapy followed by proton therapy combined with chemotherapy and subsequent surgery when possible. The study is conducted due to the complexity of delivering high-dose proton therapy to large abdominal areas and the need for multidisciplinary care in pancreatic cancer patients. Participants will receive three cycles of chemotherapy with Nab-PACLitaxel and Gemcitabine, administered intravenously over 30 minutes on days 1, 8, and 15 of each cycle. This is followed by proton therapy delivered with a simultaneous integrated boost SIB alongside daily chemotherapy with capecitabine five days per week. Proton therapy doses range between 50.4 and 60.2 Gy relative biological effectiveness in 28 fractions. After completing this combined treatment, patients will be re-evaluated around week 21, and those meeting criteria will undergo surgery via laparotomy approximately during week 22. During the study, participants will be monitored for toxicity using the Common Terminology Criteria for Adverse Events CTCAE from enrollment until six months after surgery. Perioperative mortality and complications will be assessed up to 90 days post-surgery. Additional evaluations include tumor recurrence, progression-free and overall survival, pathologic tumor response, radiologic response, and quality of life assessments using specific questionnaires up to approximately five years after therapy. The study involves comprehensive medical tests, imaging, blood work, and quality of life questionnaires to track participant status and response to treatment over an extended follow-up period.

Preoperative, Proton- Radiotherapy Combined With Chemotherapy for Borderline Resectable Pancreatic Cancer