Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06244537

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

Led by Sichuan Cancer Hospital and Research Institute · Updated on 2025-09-09

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the MR-Linac technique combined with chemotherapy and surgery in patients who have unresectable locally advanced colon cancer. This phase I single-arm clinical trial aims to explore the feasibility, safety, and potential benefits of this treatment approach in 20 patients. The study focuses on important outcomes such as the surgical removal success rate, complete response rates, progression-free survival, overall survival, and treatment-related side effects. Participants will receive a short course of radiotherapy using MR-Linac (25 Gy over 5 fractions), followed by chemotherapy with either 4 cycles of mFOLFOX6 or 3 cycles of XELOX. After chemotherapy, they will undergo radical surgical removal of the tumor. Post-surgery, patients will receive additional chemotherapy with 8 cycles of mFOLFOX6 or 5 cycles of XELOX. An initial feasibility phase will assess operational and protocol adherence before proceeding to the full study phase. Throughout the study, patients will be closely monitored for treatment completion, response rates, side effects, and surgical outcomes. Assessments include tracking pathological and clinical complete responses, surgical complications, local tumor control, disease-free survival, and overall survival over a two-year period. The study will also evaluate toxicity reactions according to standard criteria. Participation involves multiple treatment and follow-up visits as outlined, with comprehensive evaluation to understand the treatment impact and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years old
  • Able to remain still on the treatment bed for 1 to 1.5 hours
  • ECOG performance status score of 0 or 1
  • Diagnosed with colon adenocarcinoma at clinical stage cT4N0-2M0
  • Normal organ function, including specific blood counts and liver and kidney tests within set limits
  • Able to follow the study protocol throughout the research period
  • Signed written informed consent form
Not Eligible

You will not qualify if you...

  • Patients with deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H)
  • Presence of tumors other than colon adenocarcinoma
  • Claustrophobia or inability to undergo MRI or treatment due to metal implants or other reasons
  • Cancer spread to distant sites (metastasis, M1 stage)
  • Pregnant or breastfeeding women
  • Prior anti-tumor treatment
  • Use of prohibited drugs during treatment
  • Known HIV infection or AIDS
  • Significant active cardiovascular disease within 6 months prior to enrollment
  • Uncontrolled epilepsy, central nervous system disorders, or severe mental illness affecting consent or compliance
  • Organ transplant recipients on immunosuppressive therapy
  • Severe uncontrolled infections or other serious uncontrolled medical conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - Approximately 6 to 8 weeks

Participants receive MR-Linac short course radiotherapy followed by chemotherapy cycles to evaluate operational and workflow feasibility.

Multiple visits during radiotherapy and chemotherapy cycles

Treatment

Duration - Several months, including surgery and chemotherapy

Participants undergo radical surgical resection followed by postoperative chemotherapy cycles as part of the treatment regimen.

Visits for surgery and chemotherapy administration

Follow-up

Duration - Up to 2 years

Participants are monitored for treatment completion, surgical complications, and long-term outcomes including survival and disease control.

Regular follow-up visits over 2 years

Trial Site Locations

Total: 1 location

1

Sichuan Cancer Hospital & Institute, Affiliated Cancer Hospital of University of Electronic Science and Technology of China.

Chengdu, Sichuan, China, 610042

Actively Recruiting

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Research Team

Q

Qian - Peng, chief physician

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.

Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...

https://pubmed.ncbi.nlm.nih.gov/33538338

ESMO Consensus Guidelines for management of patients with colon and rectal cancer. a personalized approach to clinical decision making.

H J Schmoll, E Van Cutsem, A Stein...

https://pubmed.ncbi.nlm.nih.gov/23012255

Neoadjuvant FOLFOX 4 versus FOLFOX 4 with Cetuximab versus immediate surgery for high-risk stage II and III colon cancers: a multicentre randomised controlled phase II trial--the PRODIGE 22--ECKINOXE trial.

Mehdi Karoui, Anne Rullier, Alain Luciani...

https://pubmed.ncbi.nlm.nih.gov/26156156

Neoadjuvant chemoradiotherapy followed by surgery in patients with unresectable locally advanced colon cancer: a prospective observational study.

Hui Chang, Xin Yu, Wei-Wei Xiao...

https://pubmed.ncbi.nlm.nih.gov/29398921

Curative resection for locally advanced sigmoid colon cancer using neoadjuvant chemotherapy with FOLFOX plus panitumumab: A case report.

Kenji Tomizawa, Yuji Miura, Yudai Fukui...

https://pubmed.ncbi.nlm.nih.gov/28135678