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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025879
Receipt No. 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 2019/07/31

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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 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
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
Scientific Title:Acronym 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
Region
Japan North America

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
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 32

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Shirato
Organization Research Center for Cooperative Projects, Faculty of Medicine, Hokkaido University
Division name Department of Proton Beam Therapy Research
Zip code 060-8638
Address North 15 West 7, Kita-ku, Sapporo, Hokkaido
TEL +81-11-706-5977
Email shirato@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 Therapeutic Radiology
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
Institute Stanford Comprehensive Cancer Center
Institute
Department

Funding Source
Organization Stanford Comprehensive Cancer Center
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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 Open public recruiting
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
2021 Year 04 Month 30 Day
Date of closure to data entry
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
2019 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.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


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