Safety and Effectiveness of MR-Linac Radiotherapy Combined with Chemotherapy for Unresectable Locally Advanced Colon Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the MR-Linac technique combined with chemotherapy and surgery in patients who have unresectable locally advanced colon cancer. This phase I single-arm clinical trial aims to explore the feasibility, safety, and potential benefits of this treatment approach in 20 patients. The study focuses on important outcomes such as the surgical removal success rate, complete response rates, progression-free survival, overall survival, and treatment-related side effects. Participants will receive a short course of radiotherapy using MR-Linac 25 Gy over 5 fractions, followed by chemotherapy with either 4 cycles of mFOLFOX6 or 3 cycles of XELOX. After chemotherapy, they will undergo radical surgical removal of the tumor. Post-surgery, patients will receive additional chemotherapy with 8 cycles of mFOLFOX6 or 5 cycles of XELOX. An initial feasibility phase will assess operational and protocol adherence before proceeding to the full study phase. Throughout the study, patients will be closely monitored for treatment completion, response rates, side effects, and surgical outcomes. Assessments include tracking pathological and clinical complete responses, surgical complications, local tumor control, disease-free survival, and overall survival over a two-year period. The study will also evaluate toxicity reactions according to standard criteria. Participation involves multiple treatment and follow-up visits as outlined, with comprehensive evaluation to understand the treatment impact and safety.

Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer