RECRUITING

A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal Cancer

Conditions

Colorectal Cancer Liver Metastases Single Fraction Stereotactic Body Radiation Therapy (SBRT)Magnetic Resonance Imaging (MRI)23-285

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The researchers are doing this study to see if one session of high-dose contrast-enhanced MRI-guided SBRT (stereotactic body radiation therapy) is effective for colorectal cancer that has spread to the liver. The researchers will evaluate how well the study treatment can prevent the liver metastasis from growing and spreading. In addition, they will see whether it causes any side effects and whether there are any characteristics of the research MRI images that can predict response to treatment.

Official Title

Ablative Dose Single Fraction MRguided Colorectal Liver Metastasis SBRT

Quick Facts

Study Start:2023-11-08

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06130280

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Marsha Reyngold, MD, PhD

CONTACT

516-559-1527

reyngolm@mskcc.org

Neelam Tyagi, PhD

CONTACT

646-608-2479

Principal Investigator

Marsha Reyngold, MD, PhD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Centre, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Marsha Reyngold, MD, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-08

Study Completion Date2026-11

Study Record Updates

Study Start Date2023-11-08

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

Single Fraction Stereotactic Body Radiation Therapy (SBRT)
Magnetic Resonance Imaging (MRI)
23-285

Additional Relevant MeSH Terms

Colorectal Cancer
Liver Metastases