An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
Single Fraction Stereotactic Body Radiation Therapy Guided by Magnetic Resonance Imaging for the Treatment of Liver Metastasis from Colorectal Cancer
Trial Status: active
This phase II trial studies the effectiveness of a single treatment fraction of stereotactic body radiation therapy (SBRT) guided by magnetic resonance imaging (MRI) in treating patients with colorectal cancer that has spread from where it first started (primary site) to the liver (liver metastasis). SBRT enables precise delivery of high-dose radiation to tumors. This targeted radiation therapy kills cancer cells within the tumor without damaging healthy cells surrounding it. SBRT uses imaging scans (usually computed tomography [CT] scans) to find the location of a tumor so that the radiation can be more precisely delivered to cancer cells. MRI scans are better than CT scans at identifying liver tumors and the surrounding normal organs. In addition, MRI-based radiation machines allow radiation doctors to adjust the radiation plan at the time of treatment if any changes in organ position are detected. This helps to ensure that the tumor is targeted more precisely with greater sparing of surrounding normal organs. MRI scans are often done with contrast. In this study, Gd-EOB-DTPA, a dye that is routinely used for MRI scans of the liver is utilized. One session (fraction) of MRI-guided SBRT may shrink or stabilize colorectal cancer liver metastasis by making the treatment more precise.
Inclusion Criteria
Age ≥ 18
Histologically confirmed colorectal carcinoma and evidence of liver metastasis on imaging
Eastern Cooperative Oncology Group (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 1 cm, the individual participants can continue on the protocol provided all normal tissue constraints 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 constraints 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 constraints are met during planning)
Lesion location ≥ 0.5 cm of diaphragm
Albumin > 2 g/dl
< aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5 x ULN
Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
Negative serum pregnancy test within 14 days prior to simulation and MR-guided radiation therapy (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 Food and Drug Administration (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, whichever is longer
Extrahepatic disease outside the liver is permitted
Prior liver resection is permitted provided there is enough liver parenchyma to meet normal tissue constraints
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 defibrillators, 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
Additional locations may be listed on ClinicalTrials.gov for NCT06130280.
I. To evaluate the efficacy of 40Gy single fraction minimal margin magnetic resonance (MR)-guided SBRT for local control (LC) of colorectal cancer (CRC) liver metastasis.
SECONDARY OBJECTIVES:
I. To evaluate safety and tolerability of 40Gy single fractions MR-guided SBRT.
II. To evaluate hepatic progression-free, progression-free and overall survival (HPFS. PFS and OS, respectively).
III. To characterize MR-derived metrics in the normal liver parenchyma and treated lesions over time.
IV. To correlate MR-derived metrics at early times points with local progression defined by Response Evaluation Criteria in Solid Tumors (RECIST).
EXPLORATORY OBJECTIVE:
I. To determine patient-specific MR contrast parameters for optimal cine magnetic resonance imaging (MRI) localization and visualization of liver tumors, we will vary imaging parameters of balanced steady-state free precision (bSSFP) cine MRI sequence (ref), including offset frequency for better visualization and localization of liver tumors during single fraction 40 Gy beam delivery.
OUTLINE:
Patients receive gadoxetate disodium (Gd-EOB-DTPA) intravenously (IV) and undergo MRI scan. Ten days later, patients again receive Gd-EOB-DTPA IV, undergo MRI scan, and undergo SBRT in one treatment fraction. Patients also receive Gd-EOB-DTPA IV and undergo MRI scan during screening. In addition, patients undergo CT scans with a contrast agent or fludeoxyglucose F-18 (FDG) positron emission tomography (PET) scans throughout the trial.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
