The DRAGON 2 Trial
DRAGON 2
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)
1 other identifier
interventional
348
8 countries
23
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedFirst Posted
Study publicly available on registry
June 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
November 1, 2024
September 1, 2024
4.2 years
February 1, 2022
October 29, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Volume sufficient for resection at week 3 after the embolization
Volume sufficient for resection will be based on the first week or third week CT/MR Volumetry. Vauthey calculation for TLV will be used and the FLR volume will be measured centrally (objective panel)
3 weeks
5-year Overall Survival
survival data will be recorded up to 5-years.
5 years
Study Arms (2)
Portal Vein Embolization (PVE) alone - (control arm)
ACTIVE COMPARATORPortal Vein Embolization (PVE) alone
Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
EXPERIMENTALCombined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
Interventions
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
Eligibility Criteria
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)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Social Medical Center, South
Vienna, Vienna, 1100, Austria
Hôpital Erasme
Brussels, Brussels Capital, 1070, Belgium
CHU de Liège
Liège, Liège, 4000, Belgium
CHU-UCL Namur site Godinne
Yvoir, Namen, 5530, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Gent (9000), Belgium
Vancouver Coastal Health
Vancouver, British Columbia, V5Z 4H5, Canada
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, ON L8V 5C2, Canada
The Ottawa Hospital
Ottawa, Ontario, k1H 8L6, Canada
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5, Canada
McGill University Health Center
Montreal, Canada
IRCCS San Raffaele Hospital
Milan, Italy
Maastricht University Medical Center+
Maastricht, Limburg, 6229 HX, Netherlands
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105 AZ, Netherlands
University Medical Center Groningen
Groningen, Provincie Groningen, 9713 GZ, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, 3015, Netherlands
Amphia
Breda, Netherlands
Maxima Medisch Centrum
Eindhoven, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Linköping University Hospital
Linköping, 581 85, Sweden
Karolinska University Hospital
Stockholm, 14186, Sweden
Claraspital & Clarunis University Hospital Basel
Basel, Canton of Basel-City, CH-4058, Switzerland
Kantonsspital Winterthur (KSW)
Winterthur, 8401, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald M. van Dam, PhD
Maastricht Universitair Medisch Centrum
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2022
First Posted
June 23, 2022
Study Start
April 1, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2029
Last Updated
November 1, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- After publication
- Access Criteria
- Proposal accepted by the DRAGON Collaborative Scientific Committee
Upon reasonable request