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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003090
Receipt No. R000003751
Scientific Title A phase I trial of stereotactic body radiotherapy for limited hepatocellular carcinoma
Date of disclosure of the study information 2010/01/25
Last modified on 2018/11/06

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Basic information
Public title A phase I trial of stereotactic body radiotherapy for limited hepatocellular carcinoma
Acronym HCC-SBRT P1 Study
Scientific Title A phase I trial of stereotactic body radiotherapy for limited hepatocellular carcinoma
Scientific Title:Acronym HCC-SBRT P1 Study
Region
Japan

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

Objectives
Narrative objectives1 To elucidate the safety of stereotactic body radiotherapy for limited hepatocellular carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Incidence of dose limitting toxicity(DLT)
Key secondary outcomes Tumor response
Local progression free survival
Progression free survival
Overall survival
Adverse effects

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 A total dose of 32-64 Gy is delivered in 4 fractions over 4-8 days
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 1) Pathologically or radiologically diagnosed hepatocellular carcinoma
2) Single lesion with 5 cm or less in size
3) Ineligible for surgical resection
4) Ineligible for percutaneous local ablative therapy
5) Liver function with Child pugh score 5-6 (class A) or 7-8 (class B)
6) Normal liver volume of 800ml or more
7) Satisfy the liver tolelance dose
8) Dose not exceed the tolelance dose of surrounding normal tissues
9) ECOG Performance Status of 0-2
Key exclusion criteria 1) Uncontrolled ascites
2) Gastric/esophageal varix which needs preventive treatment
3) Tumor thrumbus in main trunk of portal vein or IVC
4) Case with critical complication
5) Simultaneous cancer
6) In pregnancy or with expectation of pregnancy

Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Itami
Organization National Cancer Center Hospital, Tokyo, Japan
Division name Division of Radiation Oncology
Zip code
Address 5-1-1, Tsukiji, Chuo-Ku, Tokyo, Japan
TEL 03-3542-2511
Email mayah1jp@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Mayahara
Organization National Cancer Center Hospital, Tokyo, Japan
Division name Division of Radiation Oncology
Zip code
Address Tsukiji 5-1-1, Chuo-Ku, Tokyo, Japan
TEL 03-3542-2511
Homepage URL
Email mayah1jp@yahoo.co.jp

Sponsor
Institute Division of Radiation Oncology and division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 25 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
2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 05 Day
Last follow-up date
2019 Year 03 Month 14 Day
Date of closure to data entry
2019 Year 03 Month 14 Day
Date trial data considered complete
2019 Year 03 Month 14 Day
Date analysis concluded
2019 Year 03 Month 14 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 25 Day
Last modified on
2018 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003751

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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