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

Study acronym: UNLACC
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 7 more changesShow less
    • Primary completion date: Jun 30, 2025 to Dec 30, 2027
    • Study sites: 0 to 1
    • Study completion date: Dec 31, 2025 to Dec 31, 2027
    • Start date changed from estimate of Feb 29, 2024 to Apr 1, 2024
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study description expanded, about 109 words
  2. Minor Start date: Jan 31, 2024 to Feb 29, 2024v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06244537
Lead Sponsor Sichuan Cancer Hospital and Research Institute
Conditions
(from sponsor)
Safety and Efficacy
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov