Actively Recruiting
Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction
Led by University Health Network, Toronto · Updated on 2026-03-04
114
Participants Needed
1
Research Sites
351 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed malignancy (colorectal adenocarcinoma, pancreatic adenocarcinoma, head and neck SCC, cervix SCC, skin SCC, or NSCLC) with liver metastases detected by imaging; biopsy preferred but not mandatory
- One to three liver metastases at least 2 cm from luminal and biliary structures
- Target lesions suitable for high/ultra-high dose SBRT: maximum of 3 lesions, each up to 6 cm in diameter
- Non-target lesions may be treated with 3- or 5-fraction SBRT
- Child-Pugh score A within one month before study entry
- Age 18 years or older
- ECOG performance status 0 to 2
- Expected life expectancy greater than 6 months
- Suitable for MR-linac treatment (able to lie on treatment couch for at least one hour)
- Ability and willingness to complete quality of life questionnaires in English
- Women of childbearing potential must use effective contraception or abstain during treatment and for 6 months after
- Women must not be pregnant or breastfeeding and must have a pregnancy test within 4 weeks before registration
- Signed informed consent according to local regulations
You will not qualify if you...
- Liver metastases from primary cancers not listed in the inclusion criteria
- Target lesions less than 2 cm from luminal or biliary structures
- More than 5 liver metastases, except in cases of oligoprogression where only 1 to 3 lesions will be treated with SBRT
- Previous radiation therapy to the abdomino-pelvic region causing significant overlap with planned treatment
- Prior liver-directed transarterial radioembolization (other liver-directed treatments allowed)
- Severe active comorbidities including recent hospitalization for lung disease, unstable angina, congestive heart failure, or myocardial infarction within 30 days
- Diseases preventing radiation therapy such as active scleroderma, lupus, or inflammatory bowel disease
- Contraindications to MRI (e.g., implanted metallic devices, pacemakers) per institutional policies
- History of claustrophobia
- Treatment volume exceeding MR-Linac capacity
- Receiving other standard anti-cancer or experimental therapies concurrently with SBRT (minimum 1 week break required)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
A
Ali Hosni, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here