RecruitingNot ApplicableNCT06244537

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

Sponsor

Sichuan Cancer Hospital and Research Institute

Enrollment

20 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Safety and Efficacy

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing MR-Linac — a cutting-edge radiation therapy machine that combines an MRI scanner with a radiation delivery system, allowing highly precise, real-time imaging during treatment — in patients with colon cancer that is locally advanced and cannot be surgically removed. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with colon adenocarcinoma (a specific type of colon cancer) that is locally advanced (stage T4) but has not spread to distant organs - You can lie still for 1 to 1.5 hours during each treatment session - Your general health score is 0 or 1 (you can perform most daily activities) - Your blood counts and organ function tests are within acceptable ranges **You may NOT be eligible if...** - Your tumor has the MSI-H or dMMR genetic feature (these cancers often respond better to immunotherapy) - You have another type of cancer in addition to colon adenocarcinoma - You have a metal implant or other contraindication to MRI - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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Interventions

RADIATIONMR-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.

Locations(1)

Sichuan Cancer Hospital & Institute, Affiliated Cancer Hospital of University of Electronic Science and Technology of China.

Chengdu, Sichuan, China

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NCT06244537

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