Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05428735




Registration number
NCT05428735
Ethics application status
Date submitted
1/02/2022
Date registered
23/06/2022

Titles & IDs
Public title
The DRAGON 2 Trial
Scientific 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)
Secondary ID [1] 0 0
NL80303.068.22
Universal Trial Number (UTN)
Trial acronym
DRAGON 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer Liver Metastases (CRLM) 0 0
Small Future Liver Remnant (FLR) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Embolization

Active comparator: Portal Vein Embolization (PVE) alone - (control arm) - Portal Vein Embolization (PVE) alone

Experimental: Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm) - Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)


Treatment: Surgery: Embolization
Portal Vein embolization with Glue by a transhepatic approach vs. PVE and Hepatic Vein Occlusion with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Volume sufficient for resection at week 3 after the embolization
Timepoint [1] 0 0
3 weeks
Primary outcome [2] 0 0
5-year Overall Survival
Timepoint [2] 0 0
5 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2029
Actual
Sample size
Target
348
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Belgium
State/province [3] 0 0
Bruxelles
Country [4] 0 0
Belgium
State/province [4] 0 0
Namen
Country [5] 0 0
Belgium
State/province [5] 0 0
Oost-Vlaanderen
Country [6] 0 0
Belgium
State/province [6] 0 0
Liège
Country [7] 0 0
Canada
State/province [7] 0 0
British Columbia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Montréal
Country [10] 0 0
Italy
State/province [10] 0 0
Milan
Country [11] 0 0
Netherlands
State/province [11] 0 0
Limburg
Country [12] 0 0
Netherlands
State/province [12] 0 0
Noord-Holland
Country [13] 0 0
Netherlands
State/province [13] 0 0
Zuid-Holland
Country [14] 0 0
Netherlands
State/province [14] 0 0
Breda
Country [15] 0 0
Netherlands
State/province [15] 0 0
Eindhoven
Country [16] 0 0
Netherlands
State/province [16] 0 0
Groningen
Country [17] 0 0
Netherlands
State/province [17] 0 0
Utrecht
Country [18] 0 0
Sweden
State/province [18] 0 0
Linköping
Country [19] 0 0
Sweden
State/province [19] 0 0
Stockholm
Country [20] 0 0
Switzerland
State/province [20] 0 0
Basel-Stadt
Country [21] 0 0
Switzerland
State/province [21] 0 0
Winterthur

Funding & Sponsors
Primary sponsor type
Other
Name
Maastricht University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ronald M. van Dam, PhD
Address 0 0
Maastricht Universitair Medisch Centrum
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sinéad James, MD, PhD-candidate
Address 0 0
Country 0 0
Phone 0 0
+31 638463945
Fax 0 0
Email 0 0
sinead.james@mumc.nl
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Upon reasonable request

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
After publication
Available to whom?
Proposal accepted by the DRAGON Collaborative Scientific Committee
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05428735