NCT05428735Recruiting
The DRAGON 2 Trial
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)
Source: ClinicalTrials.gov · Last updated 1 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 348 (estimated)
- First submitted
- 1 Feb 2022
- Start date
- 1 Apr 2022
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Maastricht University
- NCT number
- NCT05428735
What you commit to
- Study type: Interventional
- Planned participants: 348
- From 1 Apr 2022 to the primary completion date, 30 Jun 2026
- 24 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Complete response after conversion chemotherapy
Other illness
- 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
- Staging CT and (if indicated) CT/MRI brain that demonstrates non-resectable extrahepatic disease
Other
- Pregnant or lactating female.
- Premenopausal females not able or willing to commit to oral contraception
- Patients with prohibitive comorbidities, decision made by local team
- The anatomy of the liver or manifestation of tumors in relation to the liver veins prohibits the use of combined PVE/HVE.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Social Medical Center, South Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Monash Medical Centre Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Hôpital Erasme Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| CHU de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| CHU UCL Namur - Site Godinne Coordinator of this site? Confirm its status | Yvoir | Belgium | Recruiting |
| Juravinski Hospital and Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| McGill University Health Center Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Sunnybrook Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Vancouver Coastal Health Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Claraspital & Clarunis University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Kantonsspital Winterthur KSW Coordinator of this site? Confirm its status | Winterthur | Switzerland | Recruiting |
| IRCCS San Raffaele Hospital Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Amsterdam UMC, location AMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Amphia Coordinator of this site? Confirm its status | Breda | Netherlands | Not yet recruiting |
| Máxima Medisch Centrum Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Linkoping University Hospital Coordinator of this site? Confirm its status | Linköping | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.