Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer (UNLACC)

February 25, 2024 updated by: Qian Peng, Sichuan Cancer Hospital and Research Institute
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI-linac Treatment Completion Rate
Time Frame: 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).
2 years
Clinical complete response (cCR)
Time Frame: 2 years
Clinical complete response refers to the absence of detectable tumor clinically after treatment.
2 years
Pathological complete response (pCR)
Time Frame: 2 years
Pathological complete response is defined as the absence of any signs of cancer in tissue samples after treatment.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity reaction (CTC 4.0 standard）
Time Frame: long range
CTC 4.0, also known as Common Terminology Criteria for Adverse Events version 4.0, is an extensively used classification system for assessing drug toxicity. This system categorizes drug toxicity into five levels: Grade 0, Grade 1, Grade 2, Grade 3, and Grade 4.
long range
R0 resection rate
Time Frame: 2 years
During surgery, the R0 resection rate refers to the complete removal of the entire tumor with no residual abnormalities present in the surrounding normal tissue.
2 years
Surgical complications
Time Frame: 2 years
Surgical complications refers to adverse events or problems that arise during or after a surgical procedure. These complications can range from minor issues to serious complications that may have significant consequences for the patient.
2 years
Local control rate
Time Frame: 2 years
Proportion of cases in remission and stable disease after treatment, i.e., proportion of patients who did not experience disease progression.
2 years
Disease-free survival
Time Frame: 2 years
The time from the start of treatment to the first tumor recurrence/metastasis, or death of the subject due to any cause.
2 years
Overall survival
Time Frame: 2 years
Time from the start of the patient's treatment to the patient's death from any cause
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Cancer Hospital and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 29, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCCHEC-02-2024-017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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