Status:
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
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Elekta Limited
Conditions:
Colorectal Cancer
Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06130280
Start Date
November 8 2023
End Date
November 1 2026
Last Update
December 17 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725