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OpenTrials
Completed

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Innsbruck Universitaetsklinik, Innsbruck, Austria

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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

Evaluation of treatment for liver metastasis

Other

Primary outcomes

  1. Number of post-operative complications

    Time frame: 1 year

Secondary outcomes

  1. Overall survival after 2 years of follow-up

    Time frame: 3 years

  2. Progression free survival at 2 years

    Time frame: 3 years

  3. 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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