Status:
RECRUITING
The DRAGON 2 Trial
Lead Sponsor:
Maastricht University
Conditions:
Colorectal Cancer Liver Metastases (CRLM)
Small Future Liver Remnant (FLR)
Eligibility:
All Genders
18+ years
Phase:
NA
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).
Detailed Description
Resection of liver metastases from colorectal cancer (CRLM) improves survival compared to chemotherapy alone and may lead to cure in up to 40% of patients. Extended liver resections are sometimes nece...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT05428735
Start Date
April 1 2022
End Date
June 30 2029
Last Update
November 1 2024
Active Locations (24)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
2
Monash Medical Centre
Clayton, Victoria, Australia, 3168
3
Social Medical Center, South
Vienna, Vienna, Austria, 1100
4
Hôpital Erasme
Brussels, Brussels Capital, Belgium, 1070