Clinical trial NCT06130280: A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal Cancer
Official title: Ablative Dose Single Fraction MRguided Colorectal Liver Metastasis SBRT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Colorectal Cancer
Liver Metastases
Keywords: Single Fraction Stereotactic Body Radiation Therapy (SBRT)
Magnetic Resonance Imaging (MRI)
23-285
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Elekta Limited
First posted: 2023-11-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A phase II prospective trial.
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Local control rate CRC liver metastasis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Marsha Reyngold, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: