Status:
UNKNOWN
COLLISION XL: Unresectable Colorectal Liver Metastases (3-5cm): Stereotactic Body Radiotherapy vs. Microwave Ablation
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Colorectal Cancer Metastatic
Liver Metastasis Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multiple articles report that thermal ablation is a safe and effective treatment for unresectable colorectal liver metastases (CRLM) ≤3cm. However efficacy of thermal ablation decreases with increasin...
Detailed Description
Objective: The primary objective of this study is to compare efficacy of MWA to the efficacy of SBRT with regards to the primary endpoint (local tumour progression free survival at 1 year \[1-year LTP...
Eligibility Criteria
Inclusion
- 1-3 unresectable CRLM size 3-5 cm eligible for both MWA and SBRT (target lesions);
- Additional CRLM are allowed if considered either resectable or ablatable and \<3cm
- No or limited extrahepatic disease (1 extrahepatic lesion is allowed, not including positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis);
- For subjects with liver only disease the maximum number of CRLM is 10; for subjects with limited extrahepatic disease the maximum number of CRLM is 5;
- Prior focal liver treatment is allowed
- Subjects without prior focal liver treatment should be either unsuitable for 1st line chemotherapy or have progressed under/after 1st-line chemotherapy;
- Subjects with recurrent (either local or distant-hepatic) CRLM after previous focal treatment should be unsuitable for (further) systemic therapy (further downsizing or conversion to resectable disease improbable).
Exclusion
- Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites);
- Pregnant or breast-feeding subjects;
- Immunotherapy ≤ 6 weeks prior to the procedure;
- Chemotherapy ≤ 6 weeks prior to the procedure;
- Severe allergy to contrast media not controlled with premedication.
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2025
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04081168
Start Date
December 15 2020
End Date
January 15 2025
Last Update
December 20 2022
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1081 HV