One-shot radiation zaps liver tumors in colorectal cancer trial
NCT ID NCT06130280
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a single, high-dose session of MRI-guided radiation can control colorectal cancer that has spread to the liver. Researchers will treat up to 32 adults with up to 3 small liver tumors. They will track tumor growth, side effects, and look for MRI features that predict success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MR-guided single fraction stereotactic body radiation therapy (SBRT)
- What this could lead to
- If successful, this could offer a quick, one-time radiation option to control liver tumors from colorectal cancer, potentially reducing the need for multiple treatments.
- What could go wrong
- This is a small, early-phase trial with only 32 people, so results may not apply to everyone. The high radiation dose could cause side effects like liver damage or inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Nov 2026
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: * Age ≥18 * Histologically confirmed colorectal carcinoma and evidence of liver metastasis on imaging * ECOG 0-2 * \<=3 liver lesions measurable on contrast enhanced diagnostic MRI with combined size (sum of longest diameters) \< 7 cm, and individual size \< 5cm. (Subsequent simulation scans will not be used for eligibility assessment. In case of significant change in size exceeding 1cm, the individual participants can continue on the protocol provided all normal tissue contraints are met during planning). * Lesion location at least ≥ 2 cm of main, right and left portal vein on the baseline diagnostic MRI. (Subsequent simulation scans will not be used for eligibility assessment. In case of significant change in the distance between the lesion edge and critical structure exceeding 1cm, the individual participants can continue on the protocol provided all normal tissue contraints are met during planning ). * Lesion location at least ≥ 1.5 cm of luminal gastrointestinal tract (stomach, small and large bowel). (Subsequent simulation scans will not be used for eligibility assessment. In case of significant change in the distance between the lesion edge and critical structure exceeding 1cm, the individual participants can continue on the protocol provided all normal tissue contraints are met during planning). * Lesion location ≥ 0.5 cm of diaphragm * Preserved liver function as defined by: * Albumin \> 2 g/dl * \< AST/ ALT ≤ 5 x ULN * Total Bilirubin ≤ 1.5 x UL * Negative serum pregnancy test within 14 days prior to simulation and MRgRT for women of childbearing potential * Any prior systemic or hepatic artery intraarterial pump (HAIP) chemotherapy is permitted with a washout of 2 weeks * Any prior treatment with FDA-approved or investigational biologics or novel molecularly targeted therapies, including oral or IV formulations, are permitted with a washout of 1 weeks or 4 half-lives, which ever is longer * Extrahepatic disease outside the liver is permitted * Prior liver resection is permitted provided there is enough liver parenchyma to meet normal tissue contraints * Prior liver-directed RT is permitted provided departmental normal tissue constraints for re-irradiation can be met * Review by HBP DMT prior to enrollment Exclusion Criteria: * Any history of cirrhosis * History of hepatic radioembolization or selective internal radiation therapy (SIRT) * History of inflammatory bowel disease that precludes liver RT (at the discretion of the treating radiation oncologist). * Current pregnancy or breastfeeding * Men or women not using effective contraception. * Contraindication to or inability to undergo an MR scan, including, but not limited to the history of MR unsafe implants, any implanted cardiac pacemakers or deffibrilators, history of claustrophobia, and contraindications to Gd-EOB-DTPA contrast agent. * Concurrent anti-neoplastic therapy of any kind defined as receipt within 1 week of RT administration
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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
7 sites. 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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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All protocol activities)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITINGRockville Centre, New York, 11553, United States
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Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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