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New treatment option for Colorectal Cancer
Official title A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal Cancer
ClinicalTrials.gov ID: NCT06130280
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- Concurrent anti-neoplastic therapy of any kind defined as receipt within 1 week of RT administration
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.