Phase 2 Study of Sequential GEMBRAX and FOLFIRINOX Chemotherapy Followed by MRI-Guided Stereotactic Radiotherapy for Locally Advanced Pancreatic Adenocarcinoma

What this Trial Is About

Researchers are evaluating an intensified and sequential chemotherapy regimen called Gabrinox, which combines the Gembrax regimen Gemcitabine and Nab-paclitaxel followed by the Folfirinox regimen 5FU, Oxaliplatin, and Irinotecan, in patients with locally advanced pancreatic adenocarcinoma. The study also aims to assess the feasibility of adding MRI-guided stereotactic radiotherapy for patients whose cancer does not progress after chemotherapy. This phase 2 study addresses the poor prognosis and limited treatment options for this serious cancer type. Participants first receive the Gabrinox chemotherapy regimen, which consists of Gembrax given on days 1, 8, and 15 followed by a two-week rest, then Folfirinox treatment. For patients whose cancer remains stable or improves, stereotactic MRI-guided adaptive radiotherapy is administered about 5 to 6 weeks after chemotherapy ends. This radiotherapy is delivered in five sessions, each with a prescribed dose of 10 Gy on consecutive days, with at least 18 hours between sessions. Throughout the study, participants undergo regular assessments including CT scans, MRI, blood tests, and evaluations of side effects using standard scales. Researchers will monitor cancer progression, treatment tolerance, and overall survival. The primary outcomes include the rate of patients without disease progression after 4 months and the rate of acute gastrointestinal side effects within 90 days. The study may last several years, with follow-up to capture treatment effects, quality of life, and tumor response.

Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer