Comparing two methods to induce liver regeneration in colorectal cancer patients
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)
This study is testing if a new method that combines two types of vein blockage can help colorectal cancer patients with liver issues regenerate their liver better than the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 348 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 24 sites (New Haven, Connecticut and 23 other locations) |
| Trial ID | NCT05428735 on ClinicalTrials.gov |
What this trial studies
The DRAGON 2 trial is a randomized controlled trial that compares two approaches for inducing liver regeneration in patients with colorectal cancer liver metastases (CRLM) who have a small future liver remnant (FLR). Participants will be assigned to either the control group receiving portal vein embolization (PVE) alone or the interventional group receiving combined portal and hepatic vein embolization (PVE/HVE). The goal is to determine if the combined approach leads to better liver hypertrophy and reduces the risk of post-hepatectomy liver failure. This study builds on previous findings suggesting that PVE/HVE may be a superior method for enhancing liver regeneration.
Who should consider this trial
Good fit: Ideal candidates include adults with primarily unresectable or potentially resectable CRLM and a future liver remnant of less than 30%.
Not a fit: Patients with non-resectable or non-ablatable extrahepatic disease or those with hepatic malignancies other than CRLM may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could improve surgical outcomes and survival rates for patients with colorectal cancer liver metastases.
How similar studies have performed: Previous studies, including the interim analysis of the DRAGON 1 trial, have shown promising results for similar approaches, indicating potential success for this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Haven, Connecticut and 23 other locations
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- Monash Medical Centre — Clayton, Victoria, Australia (Recruiting)
- Social Medical Center, South — Vienna, State of Vienna, Austria (Not_yet_recruiting)
- Hôpital Erasme — Brussels, Brussels Capital, Belgium (Recruiting)
- CHU de Liège — Liège, Liège, Belgium (Recruiting)
- CHU-UCL Namur site Godinne — Yvoir, Namen, Belgium (Recruiting)
- UZ Gent — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
- Vancouver Coastal Health — Vancouver, British Columbia, Canada (Recruiting)
- Juravinski Hospital and Cancer Centre — Hamilton, Ontario, Canada (Recruiting)
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
- Sunnybrook Hospital — Toronto, Ontario, Canada (Recruiting)
- McGill University Health Center — Montreal, Canada (Not_yet_recruiting)
- IRCCS San Raffaele Hospital — Milan, Italy (Recruiting)
- Maastricht University Medical Center+ — Maastricht, Limburg, Netherlands (Recruiting)
- Amsterdam UMC, location AMC — Amsterdam, North Holland, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Provincie Groningen, Netherlands (Recruiting)
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Not_yet_recruiting)
- Amphia — Breda, Netherlands (Not_yet_recruiting)
- Maxima Medisch Centrum — Eindhoven, Netherlands (Recruiting)
- Universitair Medisch Centrum Utrecht — Utrecht, Netherlands (Recruiting)
- Linköping University Hospital — Linköping, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
- Claraspital & Clarunis University Hospital Basel — Basel, Canton of Basel-City, Switzerland (Recruiting)
- Kantonsspital Winterthur (KSW) — Winterthur, Switzerland (Recruiting)
Study contacts
- Principal investigator: Ronald M. van Dam, PhD — Maastricht Universitair Medisch Centrum
- Study coordinator: Sinéad James, MD, PhD-candidate
- Email: sinead.james@mumc.nl
- Phone: +31 638463945
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.