One-shot radiation blast aims to zap liver tumors better
NCT ID NCT06362395
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a single, extremely high dose of radiation, guided by advanced MRI technology, can control liver tumors that have spread from other cancers better than the usual high dose. About 114 adults with up to 3 liver metastases will be randomly assigned to receive either the experimental ultra-high dose or standard high dose radiation in one session. The goal is to see which dose provides better tumor control with fewer side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 114 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. * Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in English. The baseline assessment must be completed within required timelines, prior to treatment start. Inability (lack of comprehension in English, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. * Women of child bearing potential must use an accepted and effective method of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 6 months after the last day of RT. Sexually active males must use an accepted and effective method of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 6 months after SBRT. * Women must not be pregnant or breast-feeding. All females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 4 weeks prior to registration. All breastfeeding women should discontinue breastfeeding prior to study registration. 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) * Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices. * History of claustrophobia * The total length of treatment volume is beyond the capacity of MRL machine * Participants must not be receiving any other standard anti-cancer therapy or experimental agent concurrently with SBRT (≥1 week break of systemic therapy prior to SBRT is required).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Princess Margaret Cancer Centre
RECRUITINGToronto, Ontario, M5G 2M9, Canada
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Other studies related to the condition(s) this trial covers.
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- A new test could reveal how radiation affects the liver
- A new clue in the fight against colorectal cancer recurrence?