Chemotherapy and Tumor Clearance in Hepatic Resections fo... | NCT05273489

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

NCT05273489

Sponsor

Hospital Maciel

Status

Completed

Last Update Posted

Mar 10, 2022Actual

Enrollment

170Actual

Phase

Not provided

Conditions

Colorectal Cancer Metastatic
Liver Metastases

Interventions

Hepatectomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2004Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Oct 31, 2021Actual

First Submitted Date

Feb 24, 2022

First Submission Date that Met QC Criteria

Mar 5, 2022

First Posted Date

Mar 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2022

Last Update Posted Date

Mar 10, 2022Actual

Name	Class
University of Adelaide	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

170Actual

Name	Type	Description	Arm Group Labels	Other Names
Hepatectomy	Procedure	Neoadjuvant treatment		Chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence	Recurrence rate	From surgery to recurrence, up to 16 years
Survival	up to16 years	From surgery to death or end of the study, up to 16 years

Secondary Outcomes

Measure	Description	Time Frame
Resection margins	Resection margins of the liver resection	From surgery to death or end of the study, up to 16 years
Neoadjuvant Chemotherapy	Neoadjuvant Chemotherapy (yes or not)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Australian citizens (most of them locals) treated at The Queen Elizabeth Hospital, Adelaide, SA.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mauro A Perdomo, MD, MHA	Assitant Professor at Clinica Quirurgica 3. Universidad de la Republica. Monteviedo, Uruguay	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Data could be provided on reasonable request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 1, 2021	Mar 5, 2022	Prot_000.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D006498	Hepatectomy
D004358	Drug Therapy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided