The DRAGON 2 Trial
Key facts
- Where
- Basel and Winterthur, SwitzerlandSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you 18 years old or older?
- Has a doctor told you that the part of your liver that would be left after surgery may be too small?
- Are you pregnant or breastfeeding?
Source: NCT05428735, who can take part
Where in Switzerland
- Claraspital & Clarunis University Hospital BaselBasel, SwitzerlandTaking people
- Kantonsspital Winterthur KSWWinterthur, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Maastricht University
- Trial code
- NCT05428735
- Record updated
- 1 November 2024
- Original description
In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).Read full original descriptionShow less
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)
In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).
Inclusion: 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.
Exclusion: Complete response after conversion chemotherapy; 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; 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.