Status:
UNKNOWN
DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE
Lead Sponsor:
Maastricht University
Collaborating Sponsors:
Koningin Wilhelmina Fonds
Conditions:
Colorectal Cancer Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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). Wh...
Detailed Description
Detailed Description: Resection of liver metastases from colorectal cancer (CRLM) improves survival compared to chemotherapy alone and may lead to cure in up to 40% of patients. Surgical resectability...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT04272931
Start Date
May 8 2020
End Date
December 31 2023
Last Update
February 3 2023
Active Locations (42)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06510
2
Rush University Medical Center
Chicago, Illinois, United States, 60612
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, NSW 2050