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The DRAGON 2 Trial

ConditionsColorectal Cancer Liver Metastases (CRLM)Small Future Liver Remnant (FLR)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaastricht University

About this trial

In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Embolization

    Procedure/Surgery

    Portal Vein embolization with Glue by a transhepatic approach vs. PVE and Hepatic Vein Occlusion with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure

Treatment groups

348 Participants
are divided into 2 treatment groups
Group A: Portal Vein Embolization (PVE) alone - (control arm)Active comparator 1 intervention
Group B: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Volume sufficient for resection at week 3 after the embolization

Volume sufficient for resection will be based on the first week or third week CT/MR Volumetry. Vauthey calculation for TLV will be used and the FLR volume will be measured centrally (objective panel)

Time frame
3 weeks
2

5-year Overall Survival

survival data will be recorded up to 5-years.

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maastricht University

Lead sponsor

Source ClinicalTrials.gov
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