The DRAGON 2 Trial

Recruiting now · Not applicable

Conditions studied: Colorectal Cancer Liver Metastases (CRLM), Small Future Liver Remnant (FLR)

In brief

In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).

Key facts

Study ID

NCT05428735

Run by

Maastricht University

People needed

348

Starts

2022-04-01

Expected to finish

2029-06-30

Last updated by the study team

2024-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Kantonsspital Winterthur (KSW) — Winterthur, Switzerland (enrolling)
• Monash Medical Centre — Clayton, Victoria, Australia (enrolling)
• Linköping University Hospital — Linköping, Sweden (enrolling)
• Karolinska University Hospital — Stockholm, Sweden (enrolling)
• Claraspital & Clarunis University Hospital Basel — Basel, Canton of Basel-City, Switzerland (enrolling)
• Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• Hôpital Erasme — Brussels, Brussels Capital, Belgium (enrolling)
• CHU de Liège — Liège, Liège, Belgium (enrolling)
• CHU-UCL Namur site Godinne — Yvoir, Namen, Belgium (enrolling)
• UZ Gent — Ghent, Oost-Vlaanderen, Belgium (enrolling)
• Vancouver Coastal Health — Vancouver, British Columbia, Canada (enrolling)
• Juravinski Hospital and Cancer Centre — Hamilton, Ontario, Canada (enrolling)
• The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
• Sunnybrook Hospital — Toronto, Ontario, Canada (enrolling)
• IRCCS San Raffaele Hospital — Milan, Italy (enrolling)
• Maastricht University Medical Center+ — Maastricht, Limburg, Netherlands (enrolling)
• Amsterdam UMC, location AMC — Amsterdam, North Holland, Netherlands (enrolling)
• University Medical Center Groningen — Groningen, Provincie Groningen, Netherlands (enrolling)
• Maxima Medisch Centrum — Eindhoven, Netherlands (enrolling)
• Universitair Medisch Centrum Utrecht — Utrecht, Netherlands (enrolling)
• Social Medical Center, South — Vienna, State of Vienna, Austria
• Erasmus Medical Center — Rotterdam, South Holland, Netherlands
• Amphia — Breda, Netherlands
• McGill University Health Center — Montreal, Canada

Full record on ClinicalTrials.gov

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