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

Colorectal Cancer Clinical Trial

Official title:

Ablative Dose Single Fraction MRguided Colorectal Liver Metastasis SBRT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06130280
• Other study ID #: 23-285
• Status: Recruiting
• Phase: Phase 2
• Start date: November 8, 2023
• Est. completion date: November 2026

Study information

• Verified date: November 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Marsha Reyngold, MD, PhD
• Phone: 516-559-1527
• Email: reyngolm[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT)
40Gy single fraction treatment on Elekta Unity using Gd-EOB-DTPA-enhanced MR for image guidance.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All protocol activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Rockville Centre	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Elekta Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control rate CRC liver metastasis	by RECIST	1 year

External Links

•   Memorial Sloan Kettering Cancer Center