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Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction

Study acronym: ULTRAS
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv4
  2. Notable Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Sep 2030 to Sep 2031 · Study sites: 0 to 1 · Start date changed from estimate of Sep 2024 to Dec 5, 2024 · 1 morev3 Show 4 more changesShow less
    • Primary and study completion dates: Sep 2030 to Sep 2031
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2024 to Dec 5, 2024
    • Eligibility criteria shortened, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Start date: Jun 2024 to Sep 2024 Primary and study completion dates: Jun 2030 to Sep 2030v2 Show 1 more changeShow less
    • Primary and study completion dates: Jun 2030 to Sep 2030
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This international multi-centre phase 3 randomized control trial investigates whether giving a very high dose of radiation in a single treatment session (ultra-high dose: experimental) using advanced technology called MR-Linac is more effective than a high dose (control) for treating liver tumors that have spread from other parts of the body (liver metastases). This study also aims to identify predictors of treatment response and side effects by analyzing various factors such as imaging markers and genetic profiles. Liver metastases are common in several cancers, but surgery is often not feasible for many patients. Stereotactic body radiotherapy (SBRT), which delivers focused radiation to tumors, is an alternative treatment option. Previous studies have shown promising results with SBRT, but the optimal radiation dose for liver metastases is still uncertain. This study will look at patients with specific types of primary cancers known to respond well to SBRT. Treatment effectiveness will be assessed by monitoring tumor control, overall survival, and quality of life. By comparing ultra-high dose SBRT with standard high dose, the study aims to determine if the former can provide better tumor control with fewer side effects. If successful, this approach could offer a significant advancement in the treatment of liver metastases, potentially improving outcomes and quality of life for patients.
Trial Details
NCT Number NCT06362395
Lead Sponsor University Health Network, Toronto
Conditions Liver Metastases
Enrollment 114 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov