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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000640
Receipt No. R000000774
Scientific Title Stereotactic radiotherapy(SRT) combined with transcatheter arterial chemoembolization(TACE) for hepatocellular carcinoma: Phase II trial
Date of disclosure of the study information 2007/04/01
Last modified on 2016/04/16

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Basic information
Public title Stereotactic radiotherapy(SRT) combined with transcatheter arterial chemoembolization(TACE) for hepatocellular carcinoma: Phase II trial
Acronym SRT combined with TACE for HCC
Scientific Title Stereotactic radiotherapy(SRT) combined with transcatheter arterial chemoembolization(TACE) for hepatocellular carcinoma: Phase II trial
Scientific Title:Acronym SRT combined with TACE for HCC
Region
Japan

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 evaluate efficacy and safty of stereotactic radiotherapy(SRT) combined with transcatheter arterial chemoembolization(TACE) for hepatocellular carcinoma( size less than or equall to 4cm):Phase II study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Three year local pogression free survival
Key secondary outcomes Three year overall survival
Median overall survival
Median overall progression free survival
Median local progression free survival
Median event free survival
Type of progression
Acute complication rate
Chronic complication rate
Severe complication rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Stereotactic radiotherapy
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients are diagnosed as hepatocellular carcinoma with the following criterion of A or B, and the other inclusion criterion are the following 1-9.

A.In patients with chronic HBV or HCV hepatitis, typical tumor appearances are needed in 3 phase enhanced CT or other dynamic images.
B.In patients without chronic HBV or HCV hepatitis, pathological diagnosis is needed in first HCC and typical tumor appearances are needed in 3 phase enhanced CT or other dynamic images during follow-up after treatment of first HCC.
1.Three phase enhanced CT or other dynamic images is performed within 28 days. And the tumor maximal diameter is less than or equal to 4 cm (includes recurrence after another treatment, macroscopic residual tumor after resection, RFA or PEIT).
2.Ablation therapy is difficult or unable to perform because the tumors exist in the area such as subphrenic area and vicinity of portal vein, or the tumor shape is too complicated.
3.Surgery is out of indication or is suspected to lead poor liver function after surgery.
4.Radiation doses at organ at risk do not exceed the criterion based on the imaging study perfomed within 28 days.
5.Child-Pugh classification A or B.
6.Age older than or equal to 20 years.
7.ECOG-PS: 0-2.
8.Written approvement is given from the candidate.
Key exclusion criteria 1.Active infectious disease needing treatment except for external application.
2.In or suspected pregnancy or breast-feeding
3.mental disease which prohibit the patients from understanding this trial.
4.successive steroid use ( oral or intra-venous administration).
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuya Takeda
Organization Ofuna-Chuo Hospital
Division name Department of Radiation Oncology
Zip code
Address 6-2-24 Ofuna, Kamakura, Kanagawa
TEL 0467-45-2111
Email takeda@1994.jukuin.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Etsuo Kunieda
Organization Fuculty of Medicine, Tokai Univ.
Division name Department of Radiation Oncology
Zip code
Address 143 Shimokasuya Isehara, Kanagawa
TEL 0463-93-1121
Homepage URL
Email kunieda@tokai-u.jp

Sponsor
Institute Liver radiothrapy group
Institute
Department

Funding Source
Organization Liver radiothrapy group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2007 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/27062278
Number of participants that the trial has enrolled
Results
RESULTS: From 2007 to 2012, 101 patients were enrolled, and 90 were evaluable with a median follow-up of 41.7 months (range, 6.8-96.2 months). Thirty-two patients were treatment-naive, 20 were treated for newly diagnosed intrahepatic failure, and 38 were treated for residual or recurrent HCC as salvage therapy. Thirty-two patients did not receive TACE, 48 received insufficient TACE, and 10 attained full lipiodol accumulation. The 3-year local control rate was 96.3%, the 3-year liver-related cause-specific survival rate was 72.5%, and the overall survival rate was 66.7%. Grade 3 laboratory abnormalities were observed in 6 patients, and 8 patients had Child-Pugh scores that worsened by 2 points.
CONCLUSIONS: SBRT achieved high local control and overall survival with feasible toxicities for patients with solitary HCC, despite rather stringent conditions. SBRT can be effective against solitary HCC in treatment-naive, intrahepatic failure, residual disease, and recurrent settings, taking advantage of its distinctive characteristics.
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
2007 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2015 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 03 Month 16 Day
Last modified on
2016 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000774

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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