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)

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Other Locations
Australia
Monash Medical Centre
RECRUITING
Clayton
Austria
Social Medical Center, South
NOT_YET_RECRUITING
Vienna
Belgium
Hôpital Erasme
RECRUITING
Brussels
UZ Gent
RECRUITING
Ghent
CHU de Liège
RECRUITING
Liège
CHU-UCL Namur site Godinne
RECRUITING
Yvoir
Canada
Juravinski Hospital and Cancer Centre
RECRUITING
Hamilton
McGill University Health Center
NOT_YET_RECRUITING
Montreal
The Ottawa Hospital
RECRUITING
Ottawa
Sunnybrook Hospital
RECRUITING
Toronto
Vancouver Coastal Health
RECRUITING
Vancouver
Italy
IRCCS San Raffaele Hospital
RECRUITING
Milan
Netherlands
Amsterdam UMC, location AMC
RECRUITING
Amsterdam
Amphia
NOT_YET_RECRUITING
Breda
Maxima Medisch Centrum
RECRUITING
Eindhoven
University Medical Center Groningen
RECRUITING
Groningen
Maastricht University Medical Center+
RECRUITING
Maastricht
Erasmus Medical Center
NOT_YET_RECRUITING
Rotterdam
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
Sweden
Linköping University Hospital
RECRUITING
Linköping
Karolinska University Hospital
RECRUITING
Stockholm
Switzerland
Claraspital & Clarunis University Hospital Basel
RECRUITING
Basel
Kantonsspital Winterthur (KSW)
RECRUITING
Winterthur
Contact Information
Primary
Sinéad James, MD, PhD-candidate
sinead.james@mumc.nl
+31 638463945
Backup
Jens Smits
jens.smits@mumc.nl
+31640725518
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 348
Treatments
Active_comparator: Portal Vein Embolization (PVE) alone - (control arm)
Portal Vein Embolization (PVE) alone
Experimental: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
Related Therapeutic Areas
Sponsors
Leads: Maastricht University

This content was sourced from clinicaltrials.gov