UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036743 |
|---|---|
| Receipt number | R000041868 |
| Scientific Title | Phase II study of image-guided proton therapy for solitary primary hepatocellular carcinoma with indication for standard treatment |
| Date of disclosure of the study information | 2019/05/20 |
| Last modified on | 2021/04/12 22:17:04 |
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Basic information
Public title
Phase II study of image-guided proton therapy for solitary primary hepatocellular carcinoma with indication for standard treatment
Acronym
Phase II study of image-guided proton therapy for solitary primary hepatocellular carcinoma with indication for standard treatment
Scientific Title
Phase II study of image-guided proton therapy for solitary primary hepatocellular carcinoma with indication for standard treatment
Scientific Title:Acronym
Phase II study of image-guided proton therapy for solitary primary hepatocellular carcinoma with indication for standard treatment
Region
| Japan |
Condition
Condition
solitary primary 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 the efficacy and safety of image-guided proton therapy for solitary primary hepatocellular carcinoma that was amenable to standard treatment (resection or ablation)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2-year overall survival
Key secondary outcomes
local control rate, progression free survival,response rate,incidence of grade 3 or higher adverse events,change of quality of life (QOL)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
image-guided proton therapy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) histologically-confirmed or image-diagnosed solitary primary HCC staged as T1N0M0 (UICC TNM 7th ed.)
2) no history of previous HCC
3) patient refusal of surgery or radiofrequency ablation
4) no previous radiotherapy around the lesion
5) age: 20-80 years old
6) ECOG-PS: 0-1
7) Child-Pugh classification A5, 6 or B7
8) dose constraints of the organs at risk achievable
9) tumor diameter < 12 cm
10) written informed consent
Key exclusion criteria
1)pregnancy or lactation
2)severe psychological disorders
3)active and uncontrolled infection
4)Other cancers within 5 years
5)continuous systemic administration (oral or intravenous) of steroids
6)esophageal varix at high risk of bleeding (F3, Rc ++ or higher)
7)portal vein tumor thrombosis
8)cases in which the doctor is judged inappropriate for medical, psychological or other reasons other than the above
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ogino |
Organization
Nagoya City West Medical Center,Nagoya Proton Therapy Center
Division name
Radiation oncology
Zip code
462-8508
Address
1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL
052-991-8577
oginogio@gmail.com
Public contact
Name of contact person
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Iwata |
Organization
Nagoya City West Medical Center,Nagoya Proton Therapy Center
Division name
Radiation oncology
Zip code
462-8508
Address
1-1-1 Hirate-cho, Kita-ku, Nagoya-city, Aichi-prefecture
TEL
052-991-8577
Homepage URL
h-iwa-ncu@nifty.com
Sponsor or person
Institute
Nagoya City West Medical Center
Institute
Department
Personal name
Funding Source
Organization
Nagoya City West Medical Center,Nagoya Proton Therapy Center
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
Clinical Study Committees of the Nagoya City Hospital
Address
1-2-23 Wakamizu, Chikusa-ku, Nagoya-city, Aichi-prefecture
Tel
052-721-7171
rinsho1@higashi-hosp.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
| 2019 | Year | 05 | Month | 20 | 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
45
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
| 2013 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 14 | Day |
Last modified on
| 2021 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041868
