Phase I Study of Nab-Paclitaxel and Gemcitabine with Proton Therapy for Locally Advanced Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the highest safe dose of the chemotherapy drugs nab-paclitaxel and gemcitabine when given together with a targeted form of radiation called hypofractionated ablative proton therapy for patients with locally advanced pancreatic cancer. This phase I trial aims to find a recommended dose for future studies while reducing side effects by focusing the radiation on the main tumor area and avoiding nearby sensitive organs. Participants will receive proton therapy once a day from Monday to Friday for three weeks, totaling 15 treatment sessions. Chemotherapy with gemcitabine and nab-paclitaxel will be administered once a week on Mondays during these three weeks. After the combined treatment, surgery may be performed if the tumor becomes removable, followed by additional chemotherapy as decided by the doctor. If surgery isnt possible, chemotherapy will continue as recommended by the medical team. During the study, participants will have regular assessments including scans and lab tests to monitor tumor response, side effects, and overall health. Researchers will follow patients for up to 12 months after starting treatment or until death, whichever comes first, to measure the maximum tolerated dose of chemotherapy with radiation, tumor control, survival rates, adverse events, and quality of life. Safety and treatment effects will be closely monitored throughout this period.

Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)