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The DRAGON 2 Trial (DRAGON 2)

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Embolization
Sponsored by
Maastricht University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer Liver Metastases (CRLM)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with primarily unresectable/ potentially resectable CRLM with a FLR <30% (<40% in chemotheraphy demaged 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.

Sites / Locations

  • Monash Medical Centre
  • Social Medical Center, South
  • Hôpital Erasme
  • CHU-UCL Namur site Godinne
  • CHU de LiègeRecruiting
  • The Ottawa HospitalRecruiting
  • McGill University Health Center
  • IRCCS San Raffaele Hospital
  • Maastricht University Medical Center+
  • Amsterdam UMC, location AMC
  • Erasmus Medical Center
  • Amphia
  • Maxima Medisch CentrumRecruiting
  • University Medical Center GroningenRecruiting
  • Universitair Medisch Centrum UtrechtRecruiting
  • Linköping University HospitalRecruiting
  • Karolinska University Hospital
  • Claraspital & Clarunis University Hospital Basel
  • Kantonsspital Winterthur (KSW)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Portal Vein Embolization (PVE) alone - (control arm)

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

Arm Description

Portal Vein Embolization (PVE) alone

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

Outcomes

Primary Outcome Measures

Volume sufficient for resection at week 3 after the embolization
Volume sufficient for resection will be based on the first week or third week CT/MR Volumetry. Vauthey calculation for TLV will be used and the FLR volume will be measured centrally (objective panel)
5-year Overall Survival
survival data will be recorded up to 5-years.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2022
Last Updated
July 24, 2023
Sponsor
Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT05428735
Brief Title
The DRAGON 2 Trial
Acronym
DRAGON 2
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
Resection of liver metastases from colorectal cancer (CRLM) improves survival compared to chemotherapy alone and may lead to cure in up to 40% of patients. Extended liver resections are sometimes necessary to resect primarily unresectable/ potentially resectable (PU/PR) colorectal liver metastases. These resections are generally performed if the volume of the future liver remnant (FLR) comprises at least 30% of the total volume of the liver (without the volume of the metastases) or when liver function of the FLR on technetium-99m (99mTc) scintigraphy exceeds 2.67%/min/m2. When this liver volume or function criterion is not met, a high chance of post-hepatectomy liver failure exists. To prevent this, the induction of liver regeneration between a two-stage hepatectomy is commonly performed. The current standard procedure to induce regeneration is the embolization of the portal vein branches to the tumor carrying liver (PVE) to induce hypertrophy of the remaining part of the liver which will serve as the FLR. Recently, combined embolization of both portal and hepatic veins (PVE/HVE) has been described as a possible superior alternative to PVE, as it increases and accelerates hypertrophy of the FLR. PVE/HVE combines simultaneous embolization of the main portal vein branches into the tumor carrying liver and the hepatic vein draining this part of the liver. Preclinical studies in pigs, several retrospective studies, and the prospective DRAGON 1 interim analysis (n=60) have demonstrated the safety and feasibility of this novel technique. However, no international randomized controlled trial has been performed, in which combined PVE/HVE is compared with PVE

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Liver Metastases (CRLM), Small Future Liver Remnant (FLR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 Randomization between control and interventional group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
348 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Portal Vein Embolization (PVE) alone - (control arm)
Arm Type
Active Comparator
Arm Description
Portal Vein Embolization (PVE) alone
Arm Title
Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
Arm Type
Experimental
Arm Description
Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
Intervention Type
Procedure
Intervention Name(s)
Embolization
Intervention Description
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
Primary Outcome Measure Information:
Title
Volume sufficient for resection at week 3 after the embolization
Description
Volume sufficient for resection will be based on the first week or third week CT/MR Volumetry. Vauthey calculation for TLV will be used and the FLR volume will be measured centrally (objective panel)
Time Frame
3 weeks
Title
5-year Overall Survival
Description
survival data will be recorded up to 5-years.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sinéad James, MD, PhD-candidate
Phone
+31 638463945
Email
sinead.james@mumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Smits
Phone
+31640725518
Email
jens.smits@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M. van Dam, PhD
Organizational Affiliation
Maastricht Universitair Medisch Centrum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diederick De Boo, PhD
Facility Name
Social Medical Center, South
City
Vienna
ZIP/Postal Code
1100
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Gruenberger, MD
First Name & Middle Initial & Last Name & Degree
Tanja Friz, BSc
First Name & Middle Initial & Last Name & Degree
Thomas Gruenberger, MD
First Name & Middle Initial & Last Name & Degree
Tony Padickakudy
First Name & Middle Initial & Last Name & Degree
Tanja Fritz
First Name & Middle Initial & Last Name & Degree
Ivan Baclija
Facility Name
Hôpital Erasme
City
Brussels
State/Province
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerio Lucidi, MD PhD
First Name & Middle Initial & Last Name & Degree
Viviane van Laethem
First Name & Middle Initial & Last Name & Degree
Valerio Lucidi, MD PhD
First Name & Middle Initial & Last Name & Degree
Illario Tancredi, MD PhD
First Name & Middle Initial & Last Name & Degree
viviane van Laethem
Facility Name
CHU-UCL Namur site Godinne
City
Yvoir
State/Province
Namen
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aelxandra Dili, MD PhD
First Name & Middle Initial & Last Name & Degree
Claude Bertrand, MD PhD
First Name & Middle Initial & Last Name & Degree
Alexandra Dili, MD PhD
First Name & Middle Initial & Last Name & Degree
Jean- François De Wispelaere, MD PhD
First Name & Middle Initial & Last Name & Degree
Claude Bertrand, MD PhD
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celine Lambrecht
First Name & Middle Initial & Last Name & Degree
Olivier Detry
First Name & Middle Initial & Last Name & Degree
Celine Lambrecht
First Name & Middle Initial & Last Name & Degree
Olivier Detry, MD PhD
First Name & Middle Initial & Last Name & Degree
Laurent Gérard, MD PhD
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
k1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Martel, MD
First Name & Middle Initial & Last Name & Degree
Stephen Ryan, MD, PhD
First Name & Middle Initial & Last Name & Degree
Guillaume Martel, MD
First Name & Middle Initial & Last Name & Degree
Stephen Ryan, MD, PhD
First Name & Middle Initial & Last Name & Degree
Aklile Workneh
Facility Name
McGill University Health Center
City
Montréal
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeniffer Kalil
First Name & Middle Initial & Last Name & Degree
Peter Metrakos, Prof
First Name & Middle Initial & Last Name & Degree
David Valenti, Md PhD
Facility Name
IRCCS San Raffaele Hospital
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Aldrighetti, Prof
First Name & Middle Initial & Last Name & Degree
Stephanie Steidler
First Name & Middle Initial & Last Name & Degree
Luca Aldrighetti, Prof.
First Name & Middle Initial & Last Name & Degree
Francesco De Cobelli, Prof.
First Name & Middle Initial & Last Name & Degree
Francesca Ratti, Dr.
First Name & Middle Initial & Last Name & Degree
Simone Gusmini, Dr.
First Name & Middle Initial & Last Name & Degree
Salvatore Lamarca, Dr.
First Name & Middle Initial & Last Name & Degree
Stephanie Steidler
Facility Name
Maastricht University Medical Center+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Remon Korenblik, MD
Phone
+31637297507
Email
remon.korenblik@mumc.nl
First Name & Middle Initial & Last Name & Degree
Ronald M van Dam, MD, PhD
Email
r.van.dam@mumc.nl
First Name & Middle Initial & Last Name & Degree
Ronald M van Dam, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marc HA Bemelmans, MD, PhD
First Name & Middle Initial & Last Name & Degree
Christiaan van der Leij, MD, PhD
First Name & Middle Initial & Last Name & Degree
Remon Korenblik, MD
First Name & Middle Initial & Last Name & Degree
Bram Olij, BCs
Facility Name
Amsterdam UMC, location AMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joris I Erdmann, MD PhD
First Name & Middle Initial & Last Name & Degree
Otto M van Delden, MD PhD
First Name & Middle Initial & Last Name & Degree
Joris I Erdmann, MD PhD
First Name & Middle Initial & Last Name & Degree
Otto M van Delden, MD PhD
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk J. Grünhagen, MD PhD
First Name & Middle Initial & Last Name & Degree
Adriaan Moelker, MD PhD
First Name & Middle Initial & Last Name & Degree
Drik J Grünhagen, MD PhD
First Name & Middle Initial & Last Name & Degree
Adriaan Moelker, MD PhD
Facility Name
Amphia
City
Breda
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farshad Imani, MD PhD
First Name & Middle Initial & Last Name & Degree
Farshad Imani, MD PhD
First Name & Middle Initial & Last Name & Degree
Paul Gobardhan, MD PhD
Facility Name
Maxima Medisch Centrum
City
Eindhoven
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wouter Leclercq, MD PhD
First Name & Middle Initial & Last Name & Degree
Wouter KG Leqlercq, MD PhD
First Name & Middle Initial & Last Name & Degree
Laurens van Baardewijk, MD PhD
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marieke T de Boer, MD PhD
First Name & Middle Initial & Last Name & Degree
Jan T Bottema
First Name & Middle Initial & Last Name & Degree
Marieke T de Boer, MD PhD
First Name & Middle Initial & Last Name & Degree
Koert P de Jong
First Name & Middle Initial & Last Name & Degree
Reinhoud PH Bokkers
First Name & Middle Initial & Last Name & Degree
Jan T Bottema
First Name & Middle Initial & Last Name & Degree
Leanne van der Plas - Kemper
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maarten LJ Smits, MD PhD
First Name & Middle Initial & Last Name & Degree
Maarten LJ Smits, MD PhD
First Name & Middle Initial & Last Name & Degree
Jeroen Hagendoorn, MD PhD
First Name & Middle Initial & Last Name & Degree
Inne HM Borel Rinkes, Prof.
First Name & Middle Initial & Last Name & Degree
Rutger CG Bruijnen, MD PhD
Facility Name
Linköping University Hospital
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per Sandström, Prof.
First Name & Middle Initial & Last Name & Degree
Bergthor Bjornsson, MD
First Name & Middle Initial & Last Name & Degree
Per Sandström, Prof.
First Name & Middle Initial & Last Name & Degree
Bergthor Bjornsson, MD
First Name & Middle Initial & Last Name & Degree
Margareta Ahle, MD
First Name & Middle Initial & Last Name & Degree
Anna Lindhoff Larsson
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernesto Sparrelid, MD
First Name & Middle Initial & Last Name & Degree
Martin Delle, MD
First Name & Middle Initial & Last Name & Degree
Ernesto Sparrelid, MD
First Name & Middle Initial & Last Name & Degree
Martin Delle, MD
Facility Name
Claraspital & Clarunis University Hospital Basel
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
CH-4058
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Otto Kollmar, Prof.
First Name & Middle Initial & Last Name & Degree
Bettina Woelnerhanssen
First Name & Middle Initial & Last Name & Degree
Otto Kollmar, Prof.
First Name & Middle Initial & Last Name & Degree
Martin Hoffman, Prof.
First Name & Middle Initial & Last Name & Degree
Gabriel Hess, Dr.
First Name & Middle Initial & Last Name & Degree
Bettina Woelnershanssen
Facility Name
Kantonsspital Winterthur (KSW)
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Schadde, MD
First Name & Middle Initial & Last Name & Degree
Sabine Kern
First Name & Middle Initial & Last Name & Degree
Chistoph A Binkert, MD
First Name & Middle Initial & Last Name & Degree
Erik Schadde, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Up on reasonable request

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The DRAGON 2 Trial

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