The DRAGON 2 Trial

Description

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

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

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Study Overview

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Study Details

Study overview

In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).

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)

The DRAGON 2 Trial

Condition
Colorectal Cancer Liver Metastases (CRLM)
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Hospital, New Haven, Connecticut, United States, 06510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Maastricht University,

Ronald M. van Dam, PhD, PRINCIPAL_INVESTIGATOR, Maastricht Universitair Medisch Centrum

Study Record Dates

2029-06-30