DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE
Status unconfirmed · Not applicable
Conditions studied: Colorectal Cancer Liver Metastases
In brief
Brief Summary: Some colorectal liver metastases can only be resected after inducing liver regeneration by portal vein embolization (PVE) to increase size function of the future liver remnant (FLR). While PVE is standard, embolization of portal vein and hepatic veins (PVE/HVE) on one side of the liver may faster and more extensive liver size and function growth. PVE/HVE is a novel procedure and requires a safety and feasibility evaluation in a pretrial (DRAGON1) to then be compared in a randomized controlled trial (RCT) to PVE (DRAGON 2).
Key facts
- Study ID
- NCT04272931
- Run by
- Maastricht University
- People needed
- 111
- Starts
- 2020-05-08
- Expected to finish
- 2023-12-31
- Last updated by the study team
- 2023-02-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with primarily unresectable/potentially resectable CRLM after conversion chemotherapy with a FLR <30% in normal livers, or 40% in livers chemotherapy damaged livers.
- 18 years and older
- Patients up to ECOG 3 (not more than 50% bedbound)
- Patients with non-resected primary colorectal cancer (CRC) may be included if and only if there is an intent to remove the CRC after the liver treatment (liver first approach)
- Staging CT chest and (if symptomatic) CT/MRI excludes unresectable extrahepatic disease, while metastatic disease that may be cured in the future, is included.
- Patients with resectable lung metastases or lung metastases that and be ablated can be included only after statement about resectability/ablatability by tumor board
- Patients have to be to understand the trial and provide informed consent.
You may not qualify if…
- Patients with extrahepatic disease other than lung metastases
- Patients with metastatic disease to the lung that cannot be ablated or resected will be excluded
- Patients with intrahepatic Cholangiocarcinoma (IHCC)
- Patients with Perihilar Cholangiocarcinoma (PHCC)
- Patients with Hepatocellular Carcinoma (HCC)
- Pregnant or lactating women will not be eligible
- Potential to get pregnant has to be excluded (obligatory contraception etc.)
- Progression by modified RECIST criteria on cross-sectional imaging after conversion chemotherapy is an exclusion criterion. Complete response in cross-sectional imaging after conversion chemotherapy.
Where it is running
- Yale School of Medicine — New Haven, Connecticut, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
- Monash Health, Clayton — Clayton, Victoria, Australia
- Social Medical Center, South — Vienna, Austria
- Hôpital Erasme — Brussels, Brussels Capital, Belgium
- CHU-UCL Namur site Godinne — Yvoir, Namen, Belgium
- CHU de Liège — Liège, Belgium
- The Ottawa Hospital — Ottawa, Ontario, Canada
- McGill University Health Center — Montreal, Canada
- Klinikum Saarbrücken gGmbH — Saarbrücken, Saarland, Germany
- University Hospital Halle (Saale) — Halle, Saxony-Anhalt, Germany
- Frankfurt University Hospital — Frankfurt, Germany
- Policlinico Sant'Orsola-Malpighi — Bologna, Italy
- Fondazione Poliambulanza — Brescia, Italy
- IRCCS San Raffaele Hospital — Milan, Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy
- Maastricht University Medical Center+ — Maastricht, Limburg, Netherlands
- Amsterdam UMC, location AMC — Amsterdam, North Holland, Netherlands
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands
- Amsterdam Medical Centers, Location VUmc — Amsterdam, Netherlands
- Amphia — Breda, Netherlands
- Maxima Medisch Centrum — Eindhoven, Netherlands
- University Medical Center Groningen — Groningen, Netherlands
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.