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The DRAGON 2 Trial

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

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

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    18 and up

Critères de participation

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.

Lieu de l'étude

Vancouver Coastal Health
Vancouver Coastal Health
Vancouver, British Columbia
Canada

Contactez l'équipe d'étude

Primary Contact

Maja Segedi

Backup Contact

Maya Segedi

Sunnybrook Hospital
Sunnybrook Hospital
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Paul Karanicolas

Juravinski Hospital and Cancer Centre
Juravinski Hospital and Cancer Centre
Hamilton, Ontario
Canada

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Primary Contact

Leyo Ruo

The Ottawa Hospital
The Ottawa Hospital
Ottawa, Ontario
Canada

Contactez l'équipe d'étude

Backup Contact

Aklile Workneh

Primary Contact

Guillaume Martel, MD

Backup Contact

Stephen Ryan, MD, PhD

Étude parrainée par
Maastricht University
Participants recherchés
Plus d'informations
ID de l'étude: NCT05428735