A Phase 3 Trial Comparing TACE and TARE in Unilobar Advan... | NCT02004210

Studies
A Phase 3 Trial Comparing TACE and TARE in Unilobar Advanced Hepatocellular Carcinoma

NCT02004210

Sponsor

Seoul National University Hospital

Status

Withdrawn

Last Update Posted

Apr 27, 2016Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Hepatocellular Carcinoma

Interventions

transarterial radioembolization (TARE)
transarterial chemoembolization (TACE)

Countries

South Korea

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

Apr 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants were enrolled.

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Apr 2018Estimated

Completion Date

Apr 2018Estimated

First Submitted Date

Oct 1, 2013

First Submission Date that Met QC Criteria

Dec 2, 2013

First Posted Date

Dec 9, 2013Estimated

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

Apr 26, 2016

Last Update Posted Date

Apr 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Detailed Description

Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.

However, HCC patients are diagnosed at advanced stages in Korea. Unresectable advanced HCCs are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC by several trials. Recently,transarterial radioembolization (TARE) has been introduced for the treatment of advanced HCC. However, the efficacy of TARE compared to TACE is uncertain.

The aim of this study is to compare the efficacy of conventional transarterial chemoembolization(TACE) and transarterial radioembolization in patients with unilobar advanced hepatocellular carcinoma.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The TARE group	Experimental	transarterial radioembolization group	Procedure: transarterial radioembolization (TARE)
The TACE group	Experimental	Transarterial chemoembolization group	Procedure: transarterial chemoembolization (TACE)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transarterial radioembolization (TARE)	Procedure	transarterial radioembolization	The TARE group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	From date of randomization until the date of death	every 12 weeks, up to the time of death, up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Progression-Free Survival in the Liver	From date of randomization until the date of first documented intrahepatic tumor progression or death	every 12 weeks, up to the time of death or first documented intrahepatic tumor progression, up to 12 months
Progression-Free Survival Overall

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
Patients with advanced HCC with unilobar advanaced involvement: right lobe ± S4 segment or left lobe ± S4 segment)
Patients with single large HCC or multinodular HCC
- Single & 5cm < size < 15cm
- 2-5 nodules & maximal sized 4-15cm & sum of diameters ≦ 25cm
- Infiltrative type & unilobular involvement on liver MRI
- Segmental or lobar portal vein invasion can be included.
Age : 20 years to 80 years
ECOG Performance Status of 0 to 2
Child-Pugh class A (Child-Pugh score 5-6), B (CP score 7)
Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- WBC count ≧ 1,000/mm3
- Absolute neutrophil count > 500/mm3
- Hb ≧ 7.0 g/dL
- Platelet count > 100,000 /mm3
- Bilirubin ≦ 3 mg/dL
- Adequate clotting function: INR ≦ 2.3 or ≦ 6sec

Exclusion Criteria:

Child-Pugh score ≧ 8
ECOG Performance Status ≧ 3
Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
History of organ allograft
Patients with uncontrolled co-morbidity which needs treatment
Patients who have received prior systemic chemotherapy
Patients who have received Capecitabine within 8 weeks
Patients with extrahepatic metastasis
Main portal vein invasion
Patients with lymph node metastasis
Bilobar involvement
Bulk disease(Tumor volume >70% of the target liver volume, or tumor nodules too numerous to count)
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type