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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 February 2023 |
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Main ID: |
NCT04272931 |
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Date of registration:
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07/01/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE
DRAGON |
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Scientific title:
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DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Portal and Hepatic Vein Embolization to Accelerate Future Liver Remnant (FLR) Hypertrophy |
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Date of first enrolment:
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May 8, 2020 |
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Target sample size:
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111 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04272931 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Australia
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Austria
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Belgium
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Canada
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Germany
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Italy
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Netherlands
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Norway
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Spain
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Sweden
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Ronald M van Dam, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maastricht University Medical Center |
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Name:
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Erik Schadde, MD FACS FEBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kantonsspital Winterthur/ Rush University Medical Center, Chicago |
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Name:
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Christiaan van der Leij, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maastricht University Medical Center |
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Name:
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Christoph A Binkert, Prof.Dr.Med |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cantonal Hospital Winterthur |
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Name:
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Marc AH Bemelmans, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maastricht University Medical Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer Liver Metastases
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Intervention(s)
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Procedure: Portal and Hepatic Vein Embolization
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Primary Outcome(s)
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Ability of each center to enroll 3 patients in 12 months without mortality due to the intervention.
[Time Frame: 1 year/ 90 day mortality]
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Secondary Outcome(s)
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Liver specific complication assessment
[Time Frame: 90 days]
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Oncological effectiveness of PVE/HVE
[Time Frame: 1 year]
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Efficacy assessment: standardized future liver remnant volume
[Time Frame: 6 weeks]
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General complication assessment
[Time Frame: 90 days]
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Feasibility assessment: resection rate
[Time Frame: 1 year follow up]
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Mortality assessment
[Time Frame: 90 days]
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Overall survival after PVE/HVE
[Time Frame: 1 year follow up]
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Secondary ID(s)
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NL71535.068.19
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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