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SNCTP000003550 | NCT04272931 | BASEC2019-01704

DRAGON 1 - Training, Akreditierung, Implementierung und Sicherheitsevaluation des kombinierten Verschlusses von Portalvene und Lebervenen zur Vorbereitung eines kleinen Leberrestes vor ausgedehnten Leberresektionen

Data source: BASEC (Imported from 24.11.2020), WHO (Imported from 22.11.2020)
Changed: 22.11.2020
Disease category: Colon and Rectal Cancer, Other Cancer, Surgery

Brief description of trial (Data source: BASEC)

Um das Leberwachstum anzuregen wird normalerweise eine Methode verwendet, die das Blut, das aus dem Darm in die Leber strömt, in die gesunde Leber umleitet.(Portalvenenembolisation) In diesem Projekt wird untersucht ob die Leber nicht noch schneller wächst, wenn man sowohl das Blut, das aus dem Darm in die Leber, als auch das Blut, das aus der Leber zum Herzen zurückfliesst, umleitet. Diese neue Methode wird «kombinierte Portalvenen- und Lebervenen-Embolisation» genannt. Ziel dieser vielversprechenden Technik ist es, dass Wachstum der Leber zu beschleunigen um somit schneller die chirurgische Entfernung des kranken Leberteils durchführen zu können

Health conditions investigated (Data source: BASEC)

Evaluation einer neuen Technik um das Wachstum der gesunden Restleber bei Patienten mit Lebermetastasen, hervorgerufen durch Karzinome des Dickdarms und des Rektum, zu beschleunigen. Damit wird auch Patienten mit ausdehntem Tumorbefall der Leber, die Möglichkeit gegeben, mit einer potentiell kurativen chirurgischen Entfernung der gesamten Tumorlast behandelt zu werden.

Health conditions (Data source: WHO)

Colorectal Cancer Liver Metastases

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Das Leberwachstum wird nach einem kombinierten Verschluss der Portal- und Lebervenen untersucht. Der Verschluss der Portal-/Lebervenen erfolgt in der interventionellen Radiologie.

Interventions (Data source: WHO)

Procedure: Portal and Hepatic Vein Embolization

Criteria for participation in trial (Data source: BASEC)

Patienten mit ausgedehnten, primär nicht resezierbaren Lebermetastasen bei kolorektalem Karzinom; Patienten >18 Jahre alt; ECOG (Eastern cooperative Oncology Group classification) nicht grösser als 3 (nicht mehr als 50% als Bett gebunden.

Exclusion criteria (Data source: BASEC)

Patienten mit Karzinom des Kolons und des Rektums, die ausserdem noch Metastasen ausserhalb der Leber haben, mit einer Ausnahme: Patienten mit Lungenmetastasen, die man resezieren oder ablatieren kann. Patienten mit einer Form des Leberkarzinoms (IHCC, PHCC, HCC); Schwangere oder stillende Frauen.

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT04272931

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT04272931

Further information on trial

Date trial registered

07.01.2020

Incorporation of the first participant

08.05.2020

Recruitment status

Recruiting

Academic title (Data source: WHO)

DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization to Accelerate Future Liver Remnant (FLR) Hypertrophy

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

Ability of each center to enroll 3 patients in 12 months without mortality due to the intervention.

Secundary end point (Data source: WHO)

Efficacy assessment: standardized future liver remnant volume;Feasibility assessment: resection rate;Mortality assessment;Overall survival after PVE/HVE;Liver specific complication assessment;General complication assessment;Oncological effectiveness of PVE/HVE

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Basel, Winterthur

Countries (Data source: WHO)

Austria, Belgium, Germany, Italy, Netherlands, Norway, Spain, Sweden, Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Erik Schadde
+41789527368
erik.schadde@uzh.ch

Contact for general information (Data source: WHO)

Ronald M van Dam, MD PhD;Erik Schadde, MD FACS FEBS;Marc AH Bemelmans, MD PhD;Christiaan van der Leij, MD PhD;Christoph A Binkert, Prof.Dr.Med;Remon Korenblik, MD
Maastricht University Medical Center;Kantonsspital Winterthur/ Rush University Medical Center, Chicago;Cantonal Hospital Winterthur
+31 637297507
remon.korenblik@mumc.nl

Contact for scientific information (Data source: WHO)

Ronald M van Dam, MD PhD;Erik Schadde, MD FACS FEBS;Marc AH Bemelmans, MD PhD;Christiaan van der Leij, MD PhD;Christoph A Binkert, Prof.Dr.Med;Remon Korenblik, MD
Maastricht University Medical Center;Kantonsspital Winterthur/ Rush University Medical Center, Chicago;Cantonal Hospital Winterthur
+31 637297507
remon.korenblik@mumc.nl

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Maastricht University

Additional sponsors (Data source: WHO)

Koningin Wilhelmina Fonds

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

28.11.2019

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2019-01704

Secondary ID (Data source: WHO)

NL71535.068.19