NCT06244537Recruiting
Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 25 Jan 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Diseases
- Colorectal cancer
- NCT number
- NCT06244537
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Apr 2024 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Claustrophobia or inability to undergo MRI or treatment due to the presence of metal implants or other reasons
- Previous anti-tumor treatment
- Concurrent use of prohibited drugs for treatment
- 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
- Organ transplant surgery requiring immunosuppressive therapy
Other illness
- Known history of positive human immunodeficiency virus testing or known acquired immunodeficiency syndrome.
- 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
- Severe, uncontrolled recurrent infections or other severe, uncontrolled comorbidities
Other
- Patients with dMMR or MSI-H
- Presence of other types of tumors in addition to colon adenocarcinoma
- Distant metastasis (M1)
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sichuan Cancer Hospital & Institute, Affiliated Cancer Hospital of University of Electronic Science and Technology of China. Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.