A Prospective Colorectal Liver Metastasis Database With a... | NCT02218801

Studies
A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program

NCT02218801

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Status

Completed

Last Update Posted

May 31, 2022Actual

Enrollment

219Actual

Phase

Not provided

Conditions

Liver Metastasis
Colorectal Carcinoma

Interventions

Evaluation of treatment for liver metastasis

Countries

Austria
Belgium
Denmark
France
Germany
Italy
Netherlands
Serbia
Spain
Sweden
Switzerland
United Kingdom

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

Status Module

Record Verification Date

May 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

May 2015Actual

Primary Completion Date

Jan 2020Actual

Completion Date

Feb 2021Actual

First Submitted Date

Aug 7, 2014

First Submission Date that Met QC Criteria

Aug 15, 2014

First Posted Date

Aug 18, 2014Estimated

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

May 27, 2022

Last Update Posted Date

May 31, 2022Actual

Name	Class
European Society of Surgical Oncology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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.

Detailed Description

Not provided

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

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

219Actual

Label	Type	Description	Intervention Names
Colorectal adenocarcinoma liver metastasis		Unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer	Other: Evaluation of treatment for liver metastasis

Name	Type	Description	Arm Group Labels	Other Names
Evaluation of treatment for liver metastasis	Other		Colorectal adenocarcinoma liver metastasis

Measure	Description	Time Frame
Number of post-operative complications		1 year

Measure	Description	Time Frame
Overall survival after 2 years of follow-up		3 years
Progression free survival at 2 years		3 years
Number of post-operative complications in the first 50 patients compared to the second 50 patients

Eligibility Module

Eligibility Criteria

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)

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

Patients with liver metastasis of colorectal adenocarcinoma (unresectable, borderline resectable or initially unresectable)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Serge Evrard, Prof.	Institut Bergonié	Study Chair
Graeme Poston, Prof.	Aintree University Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Innsbruck Universitaetsklinik		Innsbruck		6020	Austria
Der Wiener Krankenanstaltenverbund - Krankenanstalt Rudolfstiftung

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases