A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program (CLIMB)

European Organisation for Research and Treatment of Cancer (EORTC)

Status: Completed

Conditions: Colorectal Carcinoma; Liver Metastasis

Treatments: Other: Evaluation of treatment for liver metastasis

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT02218801

EORTC-1409-GITCG

Details and patient eligibility

About

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.

Enrollment: 219 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

219 participants in 1 patient group

Colorectal adenocarcinoma liver metastasis

Description:

Unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer

Treatment:

Other: Evaluation of treatment for liver metastasis