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

NCT ID: NCT06244537

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MR-linac

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Patients over 18 years old

2. Patients can remain in a stationary position on the treatment bed for 1-1.5 hours

3. ECOG score 0-1

4. Pathological diagnosis of colon adenocarcinoma, clinical stage cT4N0-2M0

5. Organ function is normal, and the following conditions are required: white blood cell count ≥3.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin ≥90g/L. Total bilirubin level ≤1.5× upper limit of normal (ULN); AST and ALT levels ≤2.5 × ULN; endogenous creatinine clearance rate: 56-122ml/min; serum creatinine <1.0× ULN; serum albumin ≥30g/L.

6. Able to adhere to the study protocol during the research period

7. Signed written informed consent

Exclusion Criteria

1. Patients with dMMR or MSI-H

2. Presence of other types of tumors in addition to colon adenocarcinoma

3. Claustrophobia or inability to undergo MRI or treatment due to the presence of metal implants or other reasons

4. Distant metastasis (M1)

5. Pregnant or lactating women

6. Previous anti-tumor treatment

7. Concurrent use of prohibited drugs for treatment

8. Known history of positive human immunodeficiency virus testing or known acquired immunodeficiency syndrome.

9. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina pectoris, congestive heart failure (≥New York Heart Association class II) or severe arrhythmia requiring medication treatment

10. Individuals with uncontrolled epilepsy, central nervous system disorders or a history of mental illness, whose clinical severity may hinder signing informed consent or affect patient compliance with oral medication according to the investigator's judgement

11. Organ transplant surgery requiring immunosuppressive therapy

12. Severe, uncontrolled recurrent infections or other severe, uncontrolled comorbidities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Qian Peng

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qian - Peng, chief physician

Role: CONTACT

pengqian@scszlyy.org.cr

+086 17708130617

Facility Contacts

Qian Peng

Role: primary

lbs402889873@163.com

17708130617

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Other Identifiers

SCCHEC-02-2024-017

Identifier Type: -

Identifier Source: org_study_id