The DRAGON 2 Trial

What this study 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 join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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 this trial is running

• Yale New Haven Hospital, New Haven, Connecticut, United States
• Monash Medical Centre, Clayton, Victoria, Australia
• Social Medical Center, South, Vienna, State of Vienna, Austria
• Hôpital Erasme, Brussels, Brussels Capital, Belgium
• CHU de Liège, Liège, Liège, Belgium
• CHU-UCL Namur site Godinne, Yvoir, Namen, Belgium
• UZ Gent, Ghent, Oost-Vlaanderen, Belgium
• Vancouver Coastal Health, Vancouver, British Columbia, Canada
• Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada
• The Ottawa Hospital, Ottawa, Ontario, Canada
• Sunnybrook Hospital, Toronto, Ontario, Canada
• McGill University Health Center, Montreal, Canada

+ 12 more sites.

Who to contact

Sinéad James, MD, PhD-candidate · +31 638463945 · sinead.james@mumc.nl

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05428735.