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Trial Title:
Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer
NCT ID:
NCT06244537
Condition:
Safety and Efficacy
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
MR-Linac
unresectable locally advanced colorectal cancer
neoadjuvant radiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
MR-linac
Description:
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.
Arm group label:
MR-linac
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
February 29, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Source:
Sichuan Cancer Hospital and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06244537
