Clinical trial NCT06244537: Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer
Official title: Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Safety and Efficacy
Keywords: MR-Linac
unresectable locally advanced colorectal cancer
neoadjuvant radiotherapy
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this phase I single-arm clinical study, 20 patients with T4b 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 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 cT4bN0-2M0
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

Primary outcomes:
measure: MRI-linac Treatment Completion Rate
timeFrame: 2 years
measure: Clinical complete response (cCR)
timeFrame: 2 years
measure: Pathological complete response (pCR)
timeFrame: 2 years
Secondary outcomes:
measure: Toxicity reaction (CTC 4.0 standard）
timeFrame: long range
measure: R0 resection rate
timeFrame: 2 years
measure: Surgical complications
timeFrame: 2 years
measure: Local control rate
timeFrame: 2 years
measure: Disease-free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
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