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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05428735




Registration number
NCT05428735
Ethics application status
Date submitted
1/02/2022
Date registered
23/06/2022
Date last updated
27/07/2023

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
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Namen
Country [4] 0 0
Belgium
State/province [4] 0 0
Liège
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Montréal
Country [7] 0 0
Italy
State/province [7] 0 0
Milan
Country [8] 0 0
Netherlands
State/province [8] 0 0
Limburg
Country [9] 0 0
Netherlands
State/province [9] 0 0
Noord-Holland
Country [10] 0 0
Netherlands
State/province [10] 0 0
Zuid-Holland
Country [11] 0 0
Netherlands
State/province [11] 0 0
Breda
Country [12] 0 0
Netherlands
State/province [12] 0 0
Eindhoven
Country [13] 0 0
Netherlands
State/province [13] 0 0
Groningen
Country [14] 0 0
Netherlands
State/province [14] 0 0
Utrecht
Country [15] 0 0
Sweden
State/province [15] 0 0
Linköping
Country [16] 0 0
Sweden
State/province [16] 0 0
Stockholm
Country [17] 0 0
Switzerland
State/province [17] 0 0
Basel-Stadt
Country [18] 0 0
Switzerland
State/province [18] 0 0
Winterthur

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

Ethics approval
Ethics application status

Summary
Brief summary
In the randomized controlled DRAGON 2 trial study subjects will be randomized between two
arms, PVE alone (control group) and PVE/HVE (interventional group).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05428735
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05428735