UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013537 |
|---|---|
| Receipt number | R000015793 |
| Scientific Title | A phase II clinical trial of carbon-ion radiotherapy using 2 fractions for hepatocellular carcinoma smaller than and equal to 30mm |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2019/04/01 08:56:26 |
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Basic information
Public title
A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm
Acronym
A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm
Scientific Title
A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm
Scientific Title:Acronym
A phase II clinical trial of carbon-ion radiotherapy using 2 fractions
for hepatocellular carcinoma smaller than and equal to 30mm
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 and efficacy of carbon-ion radiotherapy using 2 fractions for small hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-year local control rate
Key secondary outcomes
Overall survival
Cause-specific survival
Normal tissue reaction
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 beam
Total dose 48.0 GyE
2 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patient with single liver tumor diagnosed hepatocellular carcinoma pathollogically or clinically.
2) The tumor is measurable and the maximum diameter of the tumor is smaller than and epual to 30mm.
3) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition)
4) The Child-Pugh score of the patient is from 5 points to 8 points.
5) Perfomance status of the patient is from 0 to 2.
6) Life expectancy of the patients is longer than one year.
7) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.
Key exclusion criteria
1) Patient recieved any other therapies for hepatocellular carcinoma within 4 weeks from the first day of the carbon-ion radiotherapy.
2) The alimentary tract is included in and adjacent to the planning target volume.
3) Patient with ascites.
4) Patient with hepatic encephalopathy.
5) Patient with sever paraesophageal varix or portal hypertention.
6) Patient with intractable esophageal or gastric varix.
7) Patients with any other active malignancies.
8) Patients with active and intractable infection at the same position where carbon-ion radiotherapy is planned.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Shioyama |
Organization
SAGA HIMAT foundation
Division name
Ion Beam Therapy Center
Zip code
Address
415 Harakoga-machi, Tosu, Saga 841-0071 Japan
TEL
0942-81-1897
shioyama-yoshiyuki@saga-himat.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Toyama |
Organization
SAGA HIMAT foundation
Division name
Ion Beam Therapy Center
Zip code
Address
415 Harakoga-machi, Tosu, Saga 841-0071 Japan
TEL
0942-81-1897
Homepage URL
toyama-shingo@saga-himat.jp
Sponsor or person
Institute
SAGA HIMAT foundation
Institute
Department
Personal name
Funding Source
Organization
SAGA HIMAT foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
佐賀国際重粒子線がん治療財団 九州国際重粒子線がん治療センター（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 27 | Day |
Last modified on
| 2019 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015793
