Trial 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
NCT ID:
NCT06130280
Condition:
Colorectal Cancer
Liver Metastases
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Conditions: Keywords:
Single Fraction Stereotactic Body Radiation Therapy (SBRT)
Magnetic Resonance Imaging (MRI)
23-285
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
A phase II prospective trial.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT)
Description:
40Gy single fraction treatment on Elekta Unity using Gd-EOB-DTPA-enhanced MR for image
guidance.
Arm group label:
MR Guided Single Fraction Stereotactic Body Radiation Therapy (SBRT)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marsha Reyngold, MD, PhD
Phone:
631-623-4267
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marsha Reyngold, MD, PhD
Phone:
631-623-4267
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marsha Reyngold, MD, PhD
Phone:
631-623-4267
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marsha Reyngold, MD, PhD
Phone:
631-623-4267
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marsha Reyngold, MD, PhD
Phone:
631-623-4267
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All protocol activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marsha Reyngold, MD, PhD
Phone:
631-623-4267
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Rockville Centre
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marsha Reyngold, MD, PhD
Phone:
631-623-4267
Start date:
November 8, 2023
Completion date:
November 2026
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
Elekta Limited
Agency class:
Industry
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06130280
http://www.mskcc.org/mskcc/html/44.cfm
