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Tests treatment safety and results for Safety and Efficacy
Official title Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer
ClinicalTrials.gov ID: NCT06244537
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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...
You likely can't join 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
See the full eligibility criteria
- 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...
- Able to adhere to the study protocol during the research period
- Signed written informed consent
- 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...
- 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...
- Organ transplant surgery requiring immunosuppressive therapy
- Severe, uncontrolled recurrent infections or other severe, uncontrolled comorbidities
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.