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NCT05428735 | RECRUITING | Colorectal Cancer Liver Metastases (CRLM)

The DRAGON 2 Trial
Sponsor:

Maastricht University

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).

Condition or disease

Colorectal Cancer Liver Metastases (CRLM)

Small Future Liver Remnant (FLR)

Intervention/treatment

Embolization

Phase

NA

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 348 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2022-04-01
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2029-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
The DRAGON 2 Trial

Location Details

NCT05428735

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Connecticut

Yale New Haven Hospital

New Haven, Connecticut, United States, 06510

RECRUITING

Australia, Victoria

Monash Medical Centre

Clayton, Victoria, Australia, 3168

NOT YET RECRUITING

Austria,

Social Medical Center, South

Vienna, Austria, 1100

RECRUITING

Belgium, Bruxelles

Erasme Hospital

Brussels, Bruxelles, Belgium, 1070

RECRUITING

Belgium, Names

Chu-un namur site godinne

Yvoir, Name, Belgium, 5530

RECRUITING

Belgium, East Flanders

To Gent

Gent, East Flanders, Belgium, Gent (9000)

RECRUITING

Belgium,

CHU de Liège

Liège, Belgium, 4000

RECRUITING

Canada, British Columbia

Vancouver Coastal Health

Vancouver, British Columbia, Canada, V5Z 4H5

RECRUITING

Canada, Ontario

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada, ON L8V 5C2

RECRUITING

Canada, Ontario

The Ottawa Hospital

Ottawa, Ontario, Canada, K1h 8l6

RECRUITING

Canada, Ontario

Sunnybrook Hospital

Toronto, Ontario, Canada, M4N 3M5

NOT YET RECRUITING

Canada,

McGill University Health Center

Montréal, Canada,

RECRUITING

Italy,

IRCCS San Raffaele Hospital

Milan, Italy,

RECRUITING

Netherlands, Limburg

Maastricht University Medical Center+

Maastricht, Limburg, Netherlands, 6229 HX

RECRUITING

Netherlands, North Holland

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands, 1105 is

NOT YET RECRUITING

Netherlands, South Holland

Erasmus Medical Center

Rotterdam, South Holland, Netherlands, 3015

NOT YET RECRUITING

Netherlands,

Amphia

Breda, Netherlands,

RECRUITING

Netherlands,

Maxima Medical Center

Eindhoven, Netherlands,

RECRUITING

Netherlands,

University Medical Center Groningen

Groningen, Netherlands, 9713 GZ

RECRUITING

Netherlands,

University Medical Center Utrecht

Utrecht, Netherlands,

RECRUITING

Sweden,

Linköping University Hospital

Linköping, Sweden, 581 85

RECRUITING

Sweden,

Karolinska University Hospital

Stockholm, Sweden, 14186

RECRUITING

Switzerland, Basel-Stadt

Claraspital & Clarunis University Hospital Basel

Basel, Basel-Stadt, Switzerland, CH-4058

RECRUITING

Switzerland,

Winterthur Cantonal Hospital (KSW)

Winterthur, Switzerland, 8401