Phase II Study Comparing Stereotactic Body Radiotherapy Plus Maintenance Therapy Versus Maintenance Therapy Alone in Adults With Advanced Pancreatic Cancer

What this Trial Is About

This research aims to assess the effectiveness of combining Stereotactic Body Radiotherapy SBRT with maintenance therapy compared to maintenance therapy alone in patients with advanced pancreatic cancer. This Phase II multicenter randomized controlled trial focuses on patients diagnosed with unresectable pancreatic adenocarcinoma who have stable disease after chemotherapy. The goal is to determine if SBRT can improve local tumor control and thus enhance overall survival outcomes in this group. Participants will be randomly assigned to one of two groups after completing at least four months of first-line chemotherapy with stable disease or partial response. One group will receive SBRT alongside maintenance chemotherapy, while the other will continue with maintenance chemotherapy alone. The chemotherapy regimen will be based on each patients initial treatment. SBRT delivers high doses of radiation precisely to the tumor, aiming to minimize harm to surrounding healthy tissues and potentially stimulate immune responses. During the study, participants will undergo evaluations of survival rates, disease progression, tumor control, and any adverse events. The primary outcome is the one-year overall survival rate, with secondary outcomes including overall survival up to 24 months, progression-free survival, local control rate, and safety monitoring throughout treatment and 30 days after the last dose. Researchers will also explore biomarkers related to treatment response. Participation involves regular follow-ups and assessments to track these outcomes until study completion.

Efficacy of Stereotactic Body Radiotherapy (SBRT) Combined With Maintenance Therapy Compared to Maintenance Therapy Alone in Advanced Pancreatic Cancer