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About
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.
Enrollment
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Volunteers
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:
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
Primary purpose
Allocation
Interventional model
Masking
32 participants in 1 patient group
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Central trial contact
Marsha Reyngold, MD, PhD; Neelam Tyagi, PhD
Data sourced from clinicaltrials.gov
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