Multidisciplinary Management of HCC in Elderly Patients | NCT03875417

Studies
Multidisciplinary Management of HCC in Elderly Patients

NCT03875417

Sponsor

Azienda Policlinico Umberto I

Status

Completed

Last Update Posted

Mar 14, 2019Actual

Enrollment

126Actual

Phase

Not provided

Conditions

HCC
Quality of Life

Interventions

liver resection
Thermic ablation
Transcatheter arterial chemoembolization

Countries

Italy

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

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, 2018Actual

Primary Completion Date

May 30, 2018Actual

Completion Date

Oct 31, 2018Actual

First Submitted Date

Mar 10, 2019

First Submission Date that Met QC Criteria

Mar 12, 2019

First Posted Date

Mar 14, 2019Actual

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 12, 2019

Last Update Posted Date

Mar 14, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Professor Stefania Brozzetti, Associate Professor, Azienda Policlinico Umberto IPrincipal Investigator

Lead Sponsor

Azienda Policlinico Umberto IOTHER

Collaborators

Not provided

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

Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.

Detailed Description

Introduction- Hepatocellular carcinoma (HCC) is the most common primary liver malignancy. It usually develops in cirrhotic liver with high recurrence rates. More than 2/3 of patients are elderly, often excluded from surgery and follow-up protocols. Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.

Materials and methods- 126 patients, aged between 65 and 90 years, submitted to liver resection for HCC were enrolled. They were divided into three classes. Class 1 included patients submitted to major resections, Class 2 to minor resections and Class 3 to minor resections associated with thermoablation. All of them were clinically and radiologically followed up. Patients who developed recurrences (Group A) were referred to further treatments (surgery, interventional radiology or pharmacological therapy). Mortality, disease-free survival (DFS), overall survival (OS) and quality of life (QoL) were evaluated and compared with non-recurrent patients (Group B).

Used interventional radiology means were Radiofrequency ablation (RF), microwaves ablation (MWA) or transcatheter arterial chemoembolization (TACE).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Patients who developed HCC recurrences after surgery and treated with re-resection, or microinvasive non-surgical means.	Procedure: liver resection Procedure: Thermic ablation Procedure: Transcatheter arterial chemoembolization
Group B		Patients who did not develop recurrences after surgery.	Procedure: liver resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
liver resection	Procedure	resection of one or more HCC nodules within the liver	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	survival in months	follow up time 1-16 years
Disease free survival	survival without recurrences in months	follow up time 1-16 years

Secondary Outcomes

Measure	Description	Time Frame
Karnofsky performance scale	evaluation of performance status in dimensionless scale 0 - 100	follow up time 1-16 years
Activity of Daily living	assess the ability to manage common routine activities evaluated in dimensionless scale 1-6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HCC patient
eligible for surgery

Exclusion Criteria:

non eligible for surgery at first HCC diagnosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

all patients submitted to surgery for HCC nodules resection between 2002 and 2017

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefania Brozzetti, Professor	Policlinico Umberto I - Sapienza università di Roma	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery "Pietro Valdoni"		Roma		00161	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006498	Hepatectomy
D000078703	Radiofrequency Ablation

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative
D000078702	Radiofrequency Therapy
D013812	Therapeutics

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