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Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT06362395•University Health Network, Toronto

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed malignancy (colorectal adenocarcinoma, pancreatic adenocarcinoma, head and neck SCC, cervix SCC, skin SCC and NSCLC) with metastatic liver disease detected on imaging. Biopsy of metastasis is preferred, but not mandatory.
•One, two or three liver metastases "target lesion", ≥ 2 cm from luminal and biliary structures
•Target lesions(s) that can receive high/ultra-high dose SBRT: Maximum number: 3, Maximum diameter of each target lesion: 6cm
•Non-target lesion(s) can be treated with 3- or 5-fraction SBRT for non-target liver metastases
•Patients must be Child-Pugh score A within one month prior to study entry.
•Must be ≥ 18 years of age.
•Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
•Expected life expectancy \> 6 months.
•Suitable for MR-linac treatment (e.g., ability to lie on the treatment couch for at least one hour)
•Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
+3 more criteria

Exclusion Criteria

•Liver metastases from primary cancer other than listed in the eligibility criteria (i.e., tumor with low α/β ratio).
•Target lesion "planned for high/ultra-high dose SBRT" in proximity (\<2cm) to luminal or biliary structures.
•Evidence of \> 5 liver metastases (exception is in cases of oligoprogression, patients may have more than 5 liver metastases, but SBRT for target lesions will be required for 1, 2, or 3 liver metastases only).
•Any previous RT to the abdomino-pelvic region that would result in significant overlap of RT volume for the current study.
•Previous liver-directed transarterial radioembolization (note that previous transarterial chemoembolization, microwave ablation, or radiofrequency ablation are permitted).
•Individuals with severe, active co-morbidity including any of the following:
•Chronic obstructive pulmonary disease or other pulmonary illness requiring hospitalization within 30 days of study registration
•Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of study registration
•Acute myocardial infarction within 30 days of study registration
•Diseases precluding RT (e.g., active scleroderma, lupus or inflammatory bowel disease)
+4 more criteria

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Key Dates

Start Date

December 5, 2024

Primary Completion Date

September 1, 2031

Completion Date

September 1, 2031

Last Updated

March 4, 2026

Enrollment

114

ESTIMATED participants

Conditions

Liver Metastases

Interventions

Magnetic resonance (MR)-guided stereotactic ablative single-fraction (SBRT)

RADIATION

Contacts

Ali Hosni, MD

CONTACT

416-946-2360 ali.hosni.abdalaty@uhn.ca

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Exosome-derived Extrahepatic Metastasis Detection By Liquid Biopsy In Colorectal Cancer Liver Metastases

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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