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NCT05273489 Clinical Trial

Chemotherapy and Tumor Clearance in Hepatic Resections for Colorectal Liver Metastases.

Liver Metastases Clinical Trial

Official title:
Effect of Chemotherapy and Tumor Clearance in Hepatic Resections for Colorectal Liver Metastases. A Single-centre Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05273489
Other study ID # CRLM1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2004
Est. completion date October 31, 2021

Study information
Verified date March 2022
Source Hospital Maciel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Retrospective analysis of a prospectively collected database of 170 patients between 2004 and 2020, who underwent liver resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital trying to determine rates and patterns of recurrence following liver resections for CRLM and concurrently, characterise clinical, pathological and treatment-related factors that could function as predictors of recurrence or survival, particularly neoadjuvant chemotherapy and tumour clearance.

Description:

This is a descriptive, observational study with retrospective analysis of a prospectively collated database. This database included all patients who underwent curative hepatic resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital (Adelaide, Australia) between December 2004 and October 2020.

Recruitment information / eligibility
Status Completed
Enrollment 170
Est. completion date October 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who underwent a liver resection for CRLM at The Queen Elizabeth Hospital between December 2004 to September 2020 Exclusion Criteria: - Patients whose procedures were abandoned due to unresectable tumour burden

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Hepatectomy
Neoadjuvant treatment

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Hospital Maciel University of Adelaide

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence Recurrence rate From surgery to recurrence, up to 16 years
Primary Survival up to16 years From surgery to death or end of the study, up to 16 years
Secondary Resection margins Resection margins of the liver resection From surgery to death or end of the study, up to 16 years
Secondary Neoadjuvant Chemotherapy Neoadjuvant Chemotherapy (yes or not) From surgery to death or end of the study, up to 16 years
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