The DRAGON 2 Trial
Recruiting · NCT05428735 · Interventional (participants receive a specific treatment) · Lead sponsor: Maastricht University
View the official record on ClinicalTrials.gov →Interventions studied
Embolization
What this trial is about
In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
24 locations listed across 1 US state.
- Yale New Haven Hospital - New Haven, Connecticut, United States
- Amphia - Breda, Netherlands
- Maxima Medisch Centrum - Eindhoven, Netherlands
- Linköping University Hospital - Linköping, Sweden
- IRCCS San Raffaele Hospital - Milan, Italy
- McGill University Health Center - Montreal, Canada
- Karolinska University Hospital - Stockholm, Sweden
- Universitair Medisch Centrum Utrecht - Utrecht, Netherlands
- Kantonsspital Winterthur (KSW) - Winterthur, Switzerland
- Vancouver Coastal Health - Vancouver, British Columbia, Canada
- Hôpital Erasme - Brussels, Brussels Capital, Belgium
- Claraspital & Clarunis University Hospital Basel - Basel, Canton of Basel-City, Switzerland
- Maastricht University Medical Center+ - Maastricht, Limburg, Netherlands
- CHU de Liège - Liège, Liège, Belgium
- CHU-UCL Namur site Godinne - Yvoir, Namen, Belgium
- Amsterdam UMC, location AMC - Amsterdam, North Holland, Netherlands
- Juravinski Hospital and Cancer Centre - Hamilton, Ontario, Canada
- The Ottawa Hospital - Ottawa, Ontario, Canada
- Sunnybrook Hospital - Toronto, Ontario, Canada
- UZ Gent - Ghent, Oost-Vlaanderen, Belgium
- University Medical Center Groningen - Groningen, Provincie Groningen, Netherlands
- Erasmus Medical Center - Rotterdam, South Holland, Netherlands
- Social Medical Center, South - Vienna, State of Vienna, Austria
- Monash Medical Centre - Clayton, Victoria, Australia