The DRAGON 2 Trial

Last updated: October 29, 2024
Sponsor: Maastricht University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Treatment

Embolization

Clinical Study ID

NCT05428735
NL80303.068.22
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 toresect the CRC after the liver treatment (liver first approach) or simultaneouslyduring 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 boardneeds to be available)

  • 18 Years and older

  • Men and women

  • Able to understand the trial and provide informed consent.

Exclusion

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-resectableextrahepatic disease

  • The anatomy of the liver or manifestation of tumors in relation to the liver veinsprohibits the use of combined PVE/HVE.

Study Design

Total Participants: 348
Treatment Group(s): 1
Primary Treatment: Embolization
Phase:
Study Start date:
April 01, 2022
Estimated Completion Date:
June 30, 2029

Study 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 necessary to resect primarily unresectable/ potentially resectable (PU/PR) colorectal liver metastases. These resections are generally performed if the volume of the future liver remnant (FLR) comprises at least 30% of the total volume of the liver (without the volume of the metastases) or when liver function of the FLR on technetium-99m (99mTc) scintigraphy exceeds 2.67%/min/m2.

When this liver volume or function criterion is not met, a high chance of post-hepatectomy liver failure exists. To prevent this, the induction of liver regeneration between a two-stage hepatectomy is commonly performed.

The current standard procedure to induce regeneration is the embolization of the portal vein branches to the tumor carrying liver (PVE) to induce hypertrophy of the remaining part of the liver which will serve as the FLR. Recently, combined embolization of both portal and hepatic veins (PVE/HVE) has been described as a possible superior alternative to PVE, as it increases and accelerates hypertrophy of the FLR. PVE/HVE combines simultaneous embolization of the main portal vein branches into the tumor carrying liver and the hepatic vein draining this part of the liver. Preclinical studies in pigs, several retrospective studies, and the prospective DRAGON 1 interim analysis (n=60) have demonstrated the safety and feasibility of this novel technique. However, no international randomized controlled trial has been performed, in which combined PVE/HVE is compared with PVE

Connect with a study center

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Social Medical Center, South

    Vienna, 1100
    Austria

    Site Not Available

  • Hôpital Erasme

    Brussels, Bruxelles 1070
    Belgium

    Active - Recruiting

  • CHU-UCL Namur site Godinne

    Yvoir, Namen 5530
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, Oost-Vlaanderen Gent (9000)
    Belgium

    Active - Recruiting

  • CHU de Liège

    Liège, 4000
    Belgium

    Active - Recruiting

  • Vancouver Coastal Health

    Vancouver, British Columbia V5Z 4H5
    Canada

    Active - Recruiting

  • Juravinski Hospital and Cancer Centre

    Hamilton, Ontario ON L8V 5C2
    Canada

    Active - Recruiting

  • The Ottawa Hospital

    Ottawa, Ontario k1H 8L6
    Canada

    Active - Recruiting

  • Sunnybrook Hospital

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • McGill University Health Center

    Montréal,
    Canada

    Site Not Available

  • IRCCS San Raffaele Hospital

    Milan,
    Italy

    Active - Recruiting

  • Maastricht University Medical Center+

    Maastricht, Limburg 6229 HX
    Netherlands

    Active - Recruiting

  • Amsterdam UMC, location AMC

    Amsterdam, Noord-Holland 1105 AZ
    Netherlands

    Active - Recruiting

  • Erasmus Medical Center

    Rotterdam, Zuid-Holland 3015
    Netherlands

    Site Not Available

  • Amphia

    Breda,
    Netherlands

    Site Not Available

  • Maxima Medisch Centrum

    Eindhoven,
    Netherlands

    Active - Recruiting

  • University Medical Center Groningen

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht,
    Netherlands

    Active - Recruiting

  • Linköping University Hospital

    Linköping, 581 85
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm, 14186
    Sweden

    Active - Recruiting

  • Claraspital & Clarunis University Hospital Basel

    Basel, Basel-Stadt CH-4058
    Switzerland

    Active - Recruiting

  • Kantonsspital Winterthur (KSW)

    Winterthur, 8401
    Switzerland

    Active - Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

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