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The DRAGON 2 Trial

NARECRUITING

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

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Patients with primarily unresectable/ potentially resectable CRLM with a FLR <30% (<40% in chemotherapy damaged livers)
  2. 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.
  3. 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)
  4. 18 Years and older
  5. Men and women
  6. Able to understand the trial and provide informed consent.

Exclusion criteria

  1. Pregnant or lactating female.
  2. Premenopausal females not able or willing to commit to oral contraception
  3. Patients with prohibitive comorbidities, decision made by local team
  4. Any patient with non-resectable or non-ablatable extrahepatic disease
  5. Patients with hepatic malignancies other than CRLM
  6. Progression of disease by RECIST criteria after cytoreduction chemotherapy
  7. Complete response after conversion chemotherapy
  8. Staging CT and (if indicated) CT/MRI brain that demonstrates non-resectable extrahepatic disease
  9. The anatomy of the liver or manifestation of tumors in relation to the liver veins prohibits the use of combined PVE/HVE.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    NA

trial

Study ID

NCT05428735

Intervention or treatment

PROCEDURE: Embolization

Conditions

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

  • Condition: Colorectal Cancer Liver Metastases (CRLM), Small Future Liver Remnant (FLR)

  • PROCEDURE: Embolization

  • Clayton, Victoria, Australia

  • Sponsor: Maastricht University

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Monash Medical Centre

Select from list below to view details:

  • Monash Medical Centre

    Clayton, Victoria, Australia

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Who is running the clinical trial?

MU

Maastricht University

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: Portal Vein Embolization (PVE) alone - (control arm)
  • Portal Vein Embolization (PVE) alone
Procedure: Embolization
    EXPERIMENTAL: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
    • Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
    Procedure: Embolization

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      Volume sufficient for resection at week 3 after the embolizationVolume 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)3 weeks
      5-year Overall Survivalsurvival data will be recorded up to 5-years.5 years

      Secondary Outcome

      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: The DRAGON 2 Trial

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