UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000025879
Receipt number	R000029751
Scientific Title	International Randomized Study of Transarterial Chemoembolization (TACE) versus Stereotactic Body Radiotherapy (SBRT) / Stereotactic Ablative Radiotherapy (SABR) for Residual or Recurrent Hepatocellular Carcinoma after Initial TACE
Date of disclosure of the study information	2017/02/06
Last modified on	2024/02/09 23:00:58

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Basic information

Public title

International Randomized Study of Transarterial Chemoembolization (TACE) versus Stereotactic Body Radiotherapy (SBRT) / Stereotactic Ablative Radiotherapy (SABR) for Residual or Recurrent Hepatocellular Carcinoma after Initial TACE

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan North America

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To determine the freedom from local progression of TACE vs SABR in patients with persistent HCC after TACE.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Assessment

Primary outcomes

Freedom from local progression (FFLP) at 6 and 12 months as defined in Section 8. (Sample size is powered for 12-month endpoint.)

Key secondary outcomes

･Progression-free survival (PFS).
･Overall survival (OS).
･Serum AFP levels.
･FFLP at 18 months.

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment

Interventions/Control_1

･Transarterial Chemoembolization: direct intravascular administration of chemotherapy and embolization material under general anesthesia/sedation.

･SABR: Stereotactic ablative radiotherapy (outpatient procedure).

Interventions/Control_2

The duration of intervention will be 1 to 16 weeks. The follow-up period will be 18 months following completion of treatment; and 3 years for survival only

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

･Confirmed hepatocellular carcinoma (HCC) by one of the following:
-Histopathology
-One radiographic technique that confirms a lesion > 1cm with arterial hypervascularization with washout on delayed phase

･Radiographic evidence of persistent, progressive, or recurrent disease in an area previously treated with TACE and determined from 3 months after initial TACE. This evaluation should be within 6 weeks of date of study eligibility.

･Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension. Multifocal lesions will be restricted to lesions that can be treated within a single target volume within the same liver segment and to an aggregate of 10 cm as long as the dose constraints to normal tissue can be met

･ECOG (Eastern Clinical Oncology Group) performance status 0, 1 or 2

･Patients with liver disease classified as Child Pugh class A or B, with score < 9

･Life expectancy > 6 months

･Age > 18 years old

･Acceptable organ function as defined below (within 2 weeks of date of eligibility):
-Albumin > 2.4 g/dL
-Total bilirubin < 3 mg/dL
-INR < 1.5
-Creatinine < 2.0 mg/dL

･Ability of the research subject or authorized legal representative to understand and have the willingness to sign a written informed consent document.

Key exclusion criteria

･Prior radiotherapy to the upper abdomen

･Prior radioembolization to the liver

･Prior RFA to index lesion

･Liver transplant

･Active gastrointestinal bleed within 2 weeks of study enrollment

･Ascites refractory to medical therapy (mild to moderate ascites is allowed)

･Women who are pregnant or breastfeeding

･Administration of chemotherapy within the last 1 month

･Extrahepatic metastases

･Participation in another concurrent treatment protocol

･Prior history of malignancy other than HCC, dermatologic basal cell or squamous cell carcinoma.

Target sample size

Research contact person

Name of lead principal investigator

1st name Norio

Middle name

Last name Katoh

Organization

Faculty of Medicine, Hokkaido University

Division name

Department of Radiation Oncology

Zip code

060-8638

Address

North 15 West 7, Kita-ku, Sapporo, Hokkaido

TEL

+81-11-706-5977

Email

noriwokatoh@med.hokudai.ac.jp

Public contact

Name of contact person

1st name Norio

Middle name

Last name Katoh

Organization

Faculty of Medicine, Hokkaido University

Division name

Department of Radiation Oncology

Zip code

060-8638

Address

North 15 West 7, Kita-ku, Sapporo, Hokkaido

TEL

+81-11-706-5977

Homepage URL

Email

noriwokatoh@med.hokudai.ac.jp

Sponsor or person

Institute

Stanford Comprehensive Cancer Center

Institute

Department

Personal name

Funding Source

Organization

Stanford Comprehensive Cancer Center

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

USA

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Hokkaido University Clinical Research Review Board

Address

North 14 West 5, Kita-ku, Sapporo, Hokkaido

Tel

+81-11-701-7636

Email

crjimu@huhp.hokudai.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 06 Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 09 Month 12 Day

Date of IRB

2017 Year 02 Month 07 Day

Anticipated trial start date

2017 Year 04 Month 20 Day

Last follow-up date

2023 Year 04 Month 30 Day

Date of closure to data entry

2026 Year 12 Month 31 Day

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2017 Year 01 Month 27 Day

Last modified on

2024 Year 02 Month 09 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029751

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name