Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- MRI-linac Treatment Completion Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: MR-linac (Radiation)
结局指标
主要结局
MRI-linac Treatment Completion Rate
时间窗: 2 years
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
Clinical complete response (cCR)
时间窗: 2 years
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
Pathological complete response (pCR)
时间窗: 2 years
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
MRI-linac Treatment Completion Rate
时间窗: 2 years
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
Clinical complete response (cCR)
时间窗: 2 years
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
Pathological complete response (pCR)
时间窗: 2 years
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
次要结局
- Toxicity reaction (CTC 4.0 standard）(long range)
- R0 resection rate(2 years)
- Local control rate(2 years)
- Disease-free survival(2 years)
- Overall survival(2 years)
- 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)
- Overall survival(2 years)
研究者
Qian Peng
chief physician
Sichuan Cancer Hospital and Research Institute