A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program
Conditions
Liver Metastasis - Colorectal Carcinoma
Conditions: official terms
Colorectal Neoplasms - Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
Liver metastasis, Colorectal carcinoma, Unresectable, Borderline resectable, Initially unresectable
Study Type
Observational [Patient Registry]
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Evaluation of treatment for liver metastasis
Type: Other
Overall Status
Not yet recruiting
Summary
This prospective database has two main objectives;

- to evaluate the complication rates, 30-day and 90-day mortality from different surgical strategies for unresectable, borderline resectable or initially unresectable liver metastasis from colorectal cancer.

- to establish baseline quality parameters for different surgical strategies for unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM) patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- With histologically proven colorectal adenocarcinoma with liver metastasis.

- With unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer assessed by a clinician or by a multi-disciplinary tumor board (MDT).

- Unresectable is defined as no possibility of completely resecting all tumor due to size, location or number of deposits.

- Borderline is defined as potentially operable but technically or biologically more challenging to resect as evaluated by the MDT.

- Initially unresectable is defined as metastasis that have been down-sized after conversion chemotherapy and evaluated by the MDT to be resectable

- discussed by a multidisciplinary team before surgery.

- Participants of the MDT must include at least one liver surgeon, one radiologist and one oncologist. They will determine the resectability of the CRLM according to local practice.

- With a surgical procedure (resection with or without portal vein embolization, intraoperative local ablative technique or a combined approach) must be planned (if indicated after preoperative systemic treatment) during the MDT.

- Age ≥ 18 years.

- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

- Any psychological, familial, or sociological condition potentially hampering understanding of the research project.

- Any other malignancy other than in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 5 years)
Location
Start Date
April 2015
Completion Date
June 2019
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Source
European Organisation for Research and Treatment of Cancer - EORTC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page