COLLISION XL: Unresectable Colorectal Liver Metastases (3-5cm): Stereotactic Body Radiotherapy vs. Microwave Ablation

Launched by AMSTERDAM UMC, LOCATION VUMC · Sep 4, 2019

Keywords

ClinConnect Summary

The COLLISION XL trial is studying two different treatments for patients with unresectable colorectal liver metastases (CRLM) that are between 3 to 5 cm in size. The two treatments being compared are Stereotactic Body Radiotherapy (SBRT) and Microwave Ablation (MWA). Both methods aim to shrink or destroy cancer tumors in the liver, but it’s not clear which one works better for tumors of this size. This research is important because while MWA is often preferred for smaller tumors, the best option for those in the 3-5 cm range hasn’t been established yet.

To participate in this trial, patients should be between 65 to 74 years old and have 1 to 3 tumors that are not removable but are eligible for both treatments. They can also have other smaller tumors if they meet certain conditions. Participants should not have serious liver issues or recent treatments like chemotherapy or immunotherapy. If eligible, participants can expect to receive either SBRT or MWA and will be closely monitored throughout the trial. This study aims to provide valuable insights into the best treatment options for patients with specific types of liver cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.