UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003090 |
|---|---|
| Receipt number | 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 | 2020/08/03 21:48:47 |
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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
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
mayah1jp@yahoo.co.jp
Sponsor or person
Institute
Division of Radiation Oncology and division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 05 | Day |
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
| 2020 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003751
