Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05428735

The DRAGON 2 Trial

Led by Maastricht University · Updated on 2024-11-01

348

Participants Needed

24

Research Sites

378 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

The DRAGON 2 Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with primarily unresectable or potentially resectable colorectal liver metastases with a future liver remnant less than 30% (less than 40% if chemotherapy damaged liver)
  • Patients with non-resected primary colorectal cancer if there is an intention to resect it after or during liver treatment
  • Patients with resectable or ablatable lung or brain metastases with tumor board confirmation
  • Adults aged 18 years and older
  • Men and women
  • Able to understand the trial and provide informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • Premenopausal women not able or willing to use oral contraception
  • Patients with prohibitive comorbidities as decided by the local medical team
  • Patients with non-resectable or non-ablatable extrahepatic disease
  • Patients with liver cancers other than colorectal liver metastases
  • Disease progression after chemotherapy by RECIST criteria
  • Complete response after conversion chemotherapy
  • Imaging showing non-resectable extrahepatic disease
  • Liver anatomy or tumor location that prevents combined PVE/HVE use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 24 locations

1

Yale New Haven Hospital

New Haven, Connecticut, United States, 06510

Actively Recruiting

2

Monash Medical Centre

Clayton, Victoria, Australia, 3168

Actively Recruiting

3

Social Medical Center, South

Vienna, State of Vienna, Austria, 1100

Not Yet Recruiting

4

Hôpital Erasme

Brussels, Brussels Capital, Belgium, 1070

Actively Recruiting

5

CHU de Liège

Liège, Liège, Belgium, 4000

Actively Recruiting

6

CHU-UCL Namur site Godinne

Yvoir, Namen, Belgium, 5530

Actively Recruiting

7

UZ Gent

Ghent, Oost-Vlaanderen, Belgium, Gent (9000)

Actively Recruiting

8

Vancouver Coastal Health

Vancouver, British Columbia, Canada, V5Z 4H5

Actively Recruiting

9

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada, ON L8V 5C2

Actively Recruiting

10

The Ottawa Hospital

Ottawa, Ontario, Canada, k1H 8L6

Actively Recruiting

11

Sunnybrook Hospital

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

12

McGill University Health Center

Montreal, Canada

Not Yet Recruiting

13

IRCCS San Raffaele Hospital

Milan, Italy

Actively Recruiting

14

Maastricht University Medical Center+

Maastricht, Limburg, Netherlands, 6229 HX

Actively Recruiting

15

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands, 1105 AZ

Actively Recruiting

16

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands, 9713 GZ

Actively Recruiting

17

Erasmus Medical Center

Rotterdam, South Holland, Netherlands, 3015

Not Yet Recruiting

18

Amphia

Breda, Netherlands

Not Yet Recruiting

19

Maxima Medisch Centrum

Eindhoven, Netherlands

Actively Recruiting

20

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Actively Recruiting

21

Linköping University Hospital

Linköping, Sweden, 581 85

Actively Recruiting

22

Karolinska University Hospital

Stockholm, Sweden, 14186

Actively Recruiting

23

Claraspital & Clarunis University Hospital Basel

Basel, Canton of Basel-City, Switzerland, CH-4058

Actively Recruiting

24

Kantonsspital Winterthur (KSW)

Winterthur, Switzerland, 8401

Actively Recruiting

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Research Team

S

Sinéad James, MD, PhD-candidate

CONTACT

J

Jens Smits

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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