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Taking people in CanadaNo phase

Blocking liver veins in colorectal cancer that has spread to liver

Compares vein blocking methods in colorectal cancer spread to liver.

Key facts

Who runs it
Maastricht University
Where
Hamilton, Montreal, Ottawa, Toronto, and Vancouver, CanadaSee the 5 sitesAlso in 8 other countries, 19 sites
Trial code
Registry title
The DRAGON 2 Trial
Status
Recruiting
People taking part
348 people, planned
Started
1 Apr 2022
Expected to end
30 Jun 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Embolization
Record updated
1 November 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose colorectal cancer has spread to the liver, and whose liver would be too small after surgery. It compares two embolization procedures.

Age
18 years and older
Sex
Men and women
Disease stage
Colorectal cancer that spread to the liver and cannot be removed at first, but may become removable. The part of the liver left after surgery is smaller than 30% (smaller than 40% if chemotherapy damaged the liver). Lung or brain spread can be included if it can be removed or ablated.
Earlier treatment
A person with the original bowel cancer not yet removed can join if the plan is to remove it later or during a liver procedure. Cancer that grew after chemotherapy, or that disappeared completely after chemotherapy, cannot join.

Main reasons for not taking part

  • Pregnant or breastfeeding women
  • Women before menopause who cannot or will not use oral contraception
  • Spread outside the liver that cannot be removed or ablated
  • Liver cancer other than colorectal cancer spread
  • Liver anatomy or tumor position that rules out the combined procedure

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Complete response after conversion chemotherapy
  • 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
  • Staging CT and (if indicated) CT/MRI brain that demonstrates non-resectable extrahepatic disease
  • Pregnant or lactating female
  • Premenopausal females not able or willing to commit to oral contraception
  • Patients with prohibitive comorbidities, decision made by local team
  • The anatomy of the liver or manifestation of tumors in relation to the liver veins prohibits the use of combined PVE/HVE

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you 18 years old or older?
  • Has a doctor told you that the part of your liver that would be left after surgery may be too small?
  • Are you pregnant or breastfeeding?

Where in Canada

Also in 8 other countries, 19 sites

  • Juravinski Hospital and Cancer CentreHamilton, CanadaContact: Leyo RuoTaking people
  • McGill University Health CenterMontreal, CanadaContact: Jeniffer KalilNot yet recruiting
  • The Ottawa HospitalOttawa, CanadaContact: Guillaume Martel, MDTaking people
  • Sunnybrook HospitalToronto, CanadaContact: Paul KaranicolasTaking people
  • Vancouver Coastal HealthVancouver, CanadaContact: Maja SegediTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Portal Vein Embolization (PVE) alone - (control arm)Existing treatment, for comparison

    Portal Vein Embolization (PVE) alone

    Treatment: Embolization

  • Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)Treatment being tested

    Treatment: Embolization

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE Alone in Patients with Colorectal Liver Cancer Metastases (CRLM) and a Small Future Liver Remnant (FLR)
Plain-language title
Blocking liver veins in colorectal cancer that has spread to liverGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05428735, who can take part
Record updated
1 November 2024