NCT06244537

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sichuan Cancer Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In this phase I single-arm clinical study, 20 patients with T4 unresectable locally advanced colon cancer are proposed to be enrolled, who will be treated with MR-Linac with short course radiotherapy (25Gy/5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and then postoperatively with 8 cycles of mFOLFOX6 or 5 cycles of XELOX. The study will assess patients' surgical R0 resection rate, pCR or cCR rate, PFS, OS, and related adverse effects of treatment, aiming to explore the feasibility, safety, and efficacy of MR-Linac in the treatment of unresectable locally advanced colon cancer.

Detailed description

Pre-specified run-in/feasibility phase. As outlined in the registered protocol, this record includes an initial feasibility (run-in) phase conducted under the same eligibility criteria and intervention as the definitive efficacy/safety phase. The run-in is designed solely to evaluate operational and workflow feasibility. The run-in is not powered for efficacy and will not test efficacy or survival hypotheses. Pre-specified feasibility thresholds for proceeding include, for example: protocol adherence ≥85-90%, adaptive-plan success ≥80-90%, and accrual feasibility ≥80% of the target. The run-in sample size is capped (≈24 patients), and its endpoints/time frames are listed under Outcome Measures. Meeting these thresholds triggers continuation to the definitive phase without changing the intervention or eligibility.

Conditions

• Safety and Efficacy

Interventions

Type	Name	Description
RADIATION	MR-linac	Patients enrolled will be treated with MR-Linac with short course radiotherapy (25Gy/5F), followed by 4 cycles of mFOLFOX6 or 3 cycles of XELOX chemotherapy, then radical surgical resection, and then postoperatively with 8 cycles of mFOLFOX6 or 5 cycles of XELOX chemotherapy.

Timeline

• Start date: 2024-04-01
• Primary completion: 2027-12-30
• Completion: 2027-12-31
• First posted: 2024-02-06
• Last updated: 2025-09-09

Locations

1 site across 1 country: China