RECRUITING

The DRAGON 2 Trial

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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)

Quick Facts

Study Start:2022-04-01
Study Completion:2029-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05428735

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with primarily unresectable/ potentially resectable CRLM with a FLR \<30% (\<40% in chemotherapy damaged livers)
  2. * 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.
  3. * 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)
  4. * 18 Years and older
  5. * Men and women
  6. * Able to understand the trial and provide informed consent.
  1. * Pregnant or lactating female.
  2. * Premenopausal females not able or willing to commit to oral contraception
  3. * Patients with prohibitive comorbidities, decision made by local team
  4. * Any patient with non-resectable or non-ablatable extrahepatic disease
  5. * Patients with hepatic malignancies other than CRLM
  6. * Progression of disease by RECIST criteria after cytoreduction chemotherapy
  7. * Complete response after conversion chemotherapy
  8. * Staging CT and (if indicated) CT/MRI brain that demonstrates non-resectable extrahepatic disease
  9. * The anatomy of the liver or manifestation of tumors in relation to the liver veins prohibits the use of combined PVE/HVE.

Contacts and Locations

Study Contact

Sinéad James, MD, PhD-candidate
CONTACT
+31 638463945
sinead.james@mumc.nl
Jens Smits
CONTACT
+31640725518
jens.smits@mumc.nl

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Maastricht University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-01
Study Completion Date2029-06-30

Study Record Updates

Study Start Date2022-04-01
Study Completion Date2029-06-30

Terms related to this study

Additional Relevant MeSH Terms

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