Back to search results

DRAGON 2 Trial: Improving Liver Regeneration for Colorectal Cancer Liver Metastases

The DRAGON 2 trial is studying a new way to help your liver grow before surgery for colorectal cancer that has spread to the liver (colorectal cancer liver metastases, or CRLM). This study compares two procedures: Portal Vein Embolization (PVE) alone, which blocks blood flow to the part of the liver with cancer to make the healthy part grow, versus PVE combined with Hepatic Vein Occlusion (HVE), which blocks both the portal and hepatic veins. The goal is to see if PVE/HVE helps the healthy part of the liver grow enough for surgery more effectively than PVE alone, and to compare long-term survival. You might be able to join if you have CRLM that is hard to remove with surgery and a small healthy liver remnant. The study is looking for 348 participants, but its current recruitment status is unclear.

Study design
This is a randomized controlled study, meaning participants will be randomly assigned to one of two treatment groups. It plans to enroll 348 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years to measure overall survival after the embolization procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05428735

The DRAGON 2 Trial

Recruiting
NAAges 18+InterventionalTreatment
Maastricht University
~348 participants
Updated 2024-11-01 on ClinicalTrials.gov
What's tested:Embolization

At a glance

Recruiting sites
20 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Volume sufficient for resection at week 3 after the embolization
Measured over 3 weeks
+1 more outcome measured

Conditions

Colorectal Cancer Liver Metastases (CRLM)
Small Future Liver Remnant (FLR)

Explore related trials

Colorectal Carcinoma

Where it's being run

24 sites across 19 states
Ontario3
Netherlands3
Sweden2
Connecticut1
Victoria1
State of Vienna1
Brussels Capital1
Liège1

Study leadership

  • Ronald M. van Dam, PhD · PRINCIPAL_INVESTIGATOR · Maastricht Universitair Medisch Centrum

Who to contact

Sinéad James, MD, PhD-candidate
[email protected]
+31 638463945
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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.

What this trial measures

  • Volume sufficient for resection at week 3 after the embolization3 weeks

    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)

  • 5-year Overall Survival5 years

    survival data will be recorded up to 5-years.