UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020344 |
|---|---|
| Receipt number | R000023504 |
| Scientific Title | A phase I clinical trial of carbon-ion radiotherapy using 4 fractions for hepatocellular carcinoma |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2017/09/24 19:53:29 |
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Basic information
Public title
A phase I clinical trial of carbon-ion radiotherapy using 4 fractions
for hepatocellular carcinoma
Acronym
A phase I clinical trial of carbon-ion radiotherapy using 4 fractions
for hepatocellular carcinoma
Scientific Title
A phase I clinical trial of carbon-ion radiotherapy using 4 fractions
for hepatocellular carcinoma
Scientific Title:Acronym
A phase I clinical trial of carbon-ion radiotherapy using 4 fractions
for hepatocellular carcinoma
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 the safety of carbon-ion radiotherapy using 4 fractions for hepatocellular carcinoma.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dose-limiting toxicity
Acute toxicity(within 6 months)
Key secondary outcomes
Response rate
Late toxicity(6 months or later)
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
| Maneuver |
Interventions/Control_1
Carbon-ion radiation therapy
Total dose 60.0 Gy(RBE)
4 fractions
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) pathollogically or clinically diagnosed hepatocellular carcinoma.
2) The tumor is measurable and tumor size is 3cm or larger and less than 10cm.
3) Absence of major portal vein, inferior vena cava or bile duct invasion.
4) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition)
5) At least 1 weeks passed after the previous therapy of hepatectomy, local ablation therapy or TACE.
6) Child-Pugh score of the patient is from 5 points to 9 points.
7) Perfomance status of the patient is from 0 to 2.
8) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.
Key exclusion criteria
1) History of radiation therapy to the lesion of interest.
2) The alimentary tract, major branch of portal vein or major bile duct was adjacent to the target lesion.
3) Patients with any other active malignancies.
4) Patient with severe comorbidity.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nakano |
Organization
Gunma University
Division name
Heavy Ion Medical Center
Zip code
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-8378
tnakano@med.gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ohno |
Organization
Gunma University
Division name
Heavy Ion Medical Center
Zip code
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-8378
Homepage URL
tohno@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Heavy Ion Medical Center
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | 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
| 2012 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 25 | Day |
Last modified on
| 2017 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023504
