NCT Number: NCT02218801
A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Innsbruck Universitaetsklinik, Innsbruck, Austria
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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 possibility of a surgical procedure (resection with or without portal vein embolization, intraoperative local ablative technique or a combined approach) assessed 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)
Treatment and study plan
Primary outcomes
-
Number of post-operative complications
Time frame: 1 year
Secondary outcomes
-
Overall survival after 2 years of follow-up
Time frame: 3 years
-
Progression free survival at 2 years
Time frame: 3 years
-
Number of post-operative complications in the first 50 patients compared to the second 50 patients
Time frame: 1 year
Sponsors and collaborators
Lead sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Network
Collaborators
- European Society of Surgical Oncology
Registry information
Acronym: CLIMB
Important dates
- Study start
- 2015
- Primary completion
- 2020
- Study completion
- 2021
- First posted
- Aug 18, 2014
- Registry last updated
- May 31, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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