The DRAGON 2 Trial
An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE Alone in Patients with Colorectal Liver Cancer Metastases (CRLM) and a Small Future Liver Remnant (FLR)
Maastricht University
348 participants
Apr 1, 2022
INTERVENTIONAL
Conditions
Summary
In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).
Eligibility
Inclusion Criteria6
- Patients with primarily unresectable/ potentially resectable CRLM with a FLR \<30% (\<40% in chemotherapy damaged livers)
- Patients with non-resected primary CRC may be included if there is an intention to resect the CRC after the liver treatment (liver first approach) or simultaneously during one of the liver procedures.
- Patients with resectable or ablatable lung or brain metastases can be included (statement about the resectability of these extrahepatic metastases by a tumor board needs to be available)
- Years and older
- Men and women
- Able to understand the trial and provide informed consent.
Exclusion Criteria9
- Pregnant or lactating female.
- Premenopausal females not able or willing to commit to oral contraception
- Patients with prohibitive comorbidities, decision made by local team
- Any patient with non-resectable or non-ablatable extrahepatic disease
- Patients with hepatic malignancies other than CRLM
- Progression of disease by RECIST criteria after cytoreduction chemotherapy
- Complete response after conversion chemotherapy
- Staging CT and (if indicated) CT/MRI brain that demonstrates non-resectable extrahepatic disease
- The anatomy of the liver or manifestation of tumors in relation to the liver veins prohibits the use of combined PVE/HVE.
Interventions
Portal Vein embolization with Glue by a transhepatic approach vs. PVE and Hepatic Vein Occlusion with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure
Locations(24)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05428735