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Clinical Trials in Canada / NCT05428735
Recruiting Not applicable

The DRAGON 2 Trial

NCT05428735 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2022-04-01
Last updated
2024-11-01

Condition(s) studied

Colorectal Cancer Liver Metastases (CRLM)Small Future Liver Remnant (FLR)

Investigational drug(s) / intervention(s)

Embolization

Embolization: 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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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) * 18 Years and older * Men and women * Able to understand the trial and provide informed consent. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Yale New Haven Hospital New Haven Connecticut Recruiting
Monash Medical Centre Clayton Victoria Recruiting
Social Medical Center, South Vienna State of Vienna Not Yet Recruiting
Hôpital Erasme Brussels Brussels Capital Recruiting
CHU de Liège Liège Liège Recruiting
CHU-UCL Namur site Godinne Yvoir Namen Recruiting
UZ Gent Ghent Oost-Vlaanderen Recruiting
Vancouver Coastal Health Vancouver British Columbia Recruiting
Juravinski Hospital and Cancer Centre Hamilton Ontario Recruiting
The Ottawa Hospital Ottawa Ontario Recruiting
Sunnybrook Hospital Toronto Ontario Recruiting
McGill University Health Center Montreal Canada Not Yet Recruiting
IRCCS San Raffaele Hospital Milan Italy Recruiting
Maastricht University Medical Center+ Maastricht Limburg Recruiting
Amsterdam UMC, location AMC Amsterdam North Holland Recruiting
University Medical Center Groningen Groningen Provincie Groningen Recruiting
Erasmus Medical Center Rotterdam South Holland Not Yet Recruiting
Amphia Breda Netherlands Not Yet Recruiting
Maxima Medisch Centrum Eindhoven Netherlands Recruiting
Universitair Medisch Centrum Utrecht Utrecht Netherlands Recruiting
Linköping University Hospital Linköping Sweden Recruiting
Karolinska University Hospital Stockholm Sweden Recruiting
Claraspital & Clarunis University Hospital Basel Basel Canton of Basel-City Recruiting
Kantonsspital Winterthur (KSW) Winterthur Switzerland Recruiting

More Maastricht University trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05428735 on ClinicalTrials.gov ↗ ← All trials in Canada