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NCT05428735Recruiting

The DRAGON 2 Trial

Official recordSimplified version

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).

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.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
No phase (N/A)
Study type
Interventional
Countries
Switzerland, Italy, Austria, United States, Australia, Belgium, Canada, Netherlands, Sweden
Sponsor
Maastricht University(Other)
Protocol no.
NL80303.068.22
Conditions
Colorectal Cancer Liver Metastases (CRLM), Small Future Liver Remnant (FLR)
Interventions
Procedure

Treatments studied

  • Embolization

Locations · 20

  • Basel, SwitzerlandClaraspital & Clarunis University Hospital BaselRecruiting at this site
  • Winterthur, SwitzerlandKantonsspital Winterthur (KSW)Recruiting at this site
  • Milan, ItalyIRCCS San Raffaele HospitalRecruiting at this site
  • New Haven, United StatesYale New Haven HospitalRecruiting at this site
  • Clayton, AustraliaMonash Medical CentreRecruiting at this site
  • Brussels, BelgiumHôpital ErasmeRecruiting at this site
  • Liège, BelgiumCHU de LiègeRecruiting at this site
  • Yvoir, BelgiumCHU-UCL Namur site GodinneRecruiting at this site
  • Ghent, BelgiumUZ GentRecruiting at this site
  • Vancouver, CanadaVancouver Coastal HealthRecruiting at this site
  • Hamilton, CanadaJuravinski Hospital and Cancer CentreRecruiting at this site
  • Ottawa, CanadaThe Ottawa HospitalRecruiting at this site
  • Toronto, CanadaSunnybrook HospitalRecruiting at this site
  • Maastricht, NetherlandsMaastricht University Medical Center+Recruiting at this site
  • Amsterdam, NetherlandsAmsterdam UMC, location AMCRecruiting at this site
  • Groningen, NetherlandsUniversity Medical Center GroningenRecruiting at this site
  • Eindhoven, NetherlandsMaxima Medisch CentrumRecruiting at this site
  • Utrecht, NetherlandsUniversitair Medisch Centrum UtrechtRecruiting at this site
  • Linköping, SwedenLinköping University HospitalRecruiting at this site
  • Stockholm, SwedenKarolinska University HospitalRecruiting at this site

In total, worldwide, 20 of the 24 sites listed in the registry are recruiting; the other 4 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: November 1, 2024).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.