The DRAGON 2 Trial
Colorectal Cancer Liver Metastases (CRLM) | 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).
null
Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Study Location
Vancouver Coastal Health
Vancouver Coastal HealthVancouver, British Columbia
Canada
Contact Study Team
Maja Segedi
Maya Segedi
Sunnybrook Hospital
Sunnybrook HospitalToronto, Ontario
Canada
Contact Study Team
Paul Karanicolas
Juravinski Hospital and Cancer Centre
Juravinski Hospital and Cancer CentreHamilton, Ontario
Canada
Contact Study Team
Leyo Ruo
The Ottawa Hospital
The Ottawa HospitalOttawa, Ontario
Canada
Contact Study Team
Aklile Workneh
Guillaume Martel, MD
Stephen Ryan, MD, PhD
- Study Sponsored By
- Maastricht University
- Participants Required
- More Information
- Study ID:
NCT05428735