Recruiting

Observational Study

Sponsor:

Maastricht University

Code:

NCT05428735

Conditions

Colorectal Cancer Liver Metastases (CRLM)

Small Future Liver Remnant (FLR)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Embolization

Study Details

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).

Conditions

Colorectal Cancer Liver Metastases (CRLM)

Small Future Liver Remnant (FLR)

Study ID

NCT05428735

Start date

Apr 1, 2022

Status verified date

Sep, 2024

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

348 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Portal Vein Embolization (PVE) alone - (control arm)

Portal Vein Embolization (PVE) alone

experimental: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)

Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)

Interventions

Embolization

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

Primary outcome measure

  • Volume sufficient for resection at week 3 after the embolization [ Time Frame: 3 weeks ]
  • 5-year Overall Survival [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Sinéad James, MD, PhD-candidate

+31 638463945sinead.james@mumc.nl

Jens Smits

+31640725518jens.smits@mumc.nl

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Vancouver Coastal Health

Recruiting

Vancouver, British Columbia, Canada, V5Z 4H5

Juravinski Hospital and Cancer Centre

Recruiting

Hamilton, Ontario, Canada, ON L8V 5C2

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, k1H 8L6

Sunnybrook Hospital

Recruiting

Toronto, Ontario, Canada, M4N 3M5

More Information

Sponsor

Maastricht University

Last update posted

Nov 1, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maastricht University on 2024-11-01.