High-dose MRI-guided radiation therapy for liver cancer from colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a single session of high-dose stereotactic body radiation therapy (SBRT) guided by magnetic resonance imaging (MRI) in patients with liver metastasis from colorectal cancer. Researchers aim to determine if this treatment can prevent the growth and spread of liver metastases while assessing potential side effects. Additionally, the study will explore whether specific characteristics observed in MRI images can predict the treatment response. The trial is designed for patients with a limited number of liver lesions that meet specific size and location criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All protocol activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Marsha Reyngold, MD, PhD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Marsha Reyngold, MD, PhD
• Email: reyngolm@mskcc.org
• Phone: 516-559-1527

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.