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

NCT06244537 | Recruiting

• 1 other identifier: SCCHEC-02-2024-017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety and Efficacy

Keywords

MR-Linac; unresectable locally advanced colorectal cancer; neoadjuvant radiotherapy

Outcome Measures

Primary Outcomes (3)

• MRI-linac Treatment Completion Rate

  Is adaptive radiotherapy guided by MRI feasible for patients with locally advanced unresectable colon cancer. The feasibility of each patient will be recorded as a binary variable (1=feasible; 0=not feasible). Completion Rate = Number of Completions / Total ITT Enrollment

  2 years

• Clinical complete response (cCR)

  Clinical complete response refers to the absence of detectable tumor clinically after treatment. Number of cCR cases/Number of cases completed for follow-up evaluation

  2 years

• Pathological complete response (pCR)

  Pathological complete response is defined as the absence of any signs of cancer in tissue samples after treatment. Number of pCR cases / Number of completed surgeries

  2 years

Secondary Outcomes (6)

• Toxicity reaction (CTC 4.0 standard）

  long range

• R0 resection rate

  2 years

• Surgical complications

  2 years

• Local control rate

  2 years

• Disease-free survival

  2 years

Other Outcomes (1)

• Online adaptation time, compliance rate, technical success rate

  8 months.

Study Arms (1)

MR-linac

EXPERIMENTAL

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.

Radiation: MR-linac

Interventions

MR-linac 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.

MR-linac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old
• Patients can remain in a stationary position on the treatment bed for 1-1.5 hours
• ECOG score 0-1
• Pathological diagnosis of colon adenocarcinoma, clinical stage cT4N0-2M0
• 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.
• Able to adhere to the study protocol during the research period
• Signed written informed consent

You may not qualify if:

• Patients with dMMR or MSI-H
• Presence of other types of tumors in addition to colon adenocarcinoma
• Claustrophobia or inability to undergo MRI or treatment due to the presence of metal implants or other reasons
• Distant metastasis (M1)
• Pregnant or lactating women
• Previous anti-tumor treatment
• Concurrent use of prohibited drugs for treatment
• Known history of positive human immunodeficiency virus testing or known acquired immunodeficiency syndrome.
• 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
• 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
• Organ transplant surgery requiring immunosuppressive therapy
• Severe, uncontrolled recurrent infections or other severe, uncontrolled comorbidities

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

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

Chengdu, Sichuan, 610042, China

RECRUITING

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Central Study Contacts

Qian - Peng, chief physician

CONTACT

+086 17708130617; pengqian@scszlyy.org.cr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 6, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)