RecruitingColorectal Cancer Liver Metastases (CRLM)Small Future Liver Remnant (FLR)
The DRAGON 2 Trial
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).
Sponsor: Maastricht University
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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
Where it's recruiting
Connecticut
New Haven
Source: ClinicalTrials.gov · NCT05428735 · last updated 2024-11-01