UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020571 |
|---|---|
| Receipt number | R000023750 |
| Scientific Title | Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703) |
| Date of disclosure of the study information | 2016/01/14 |
| Last modified on | 2018/01/15 18:35:41 |
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Basic information
Public title
Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703)
Acronym
Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703)
Scientific Title
Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703)
Scientific Title:Acronym
Efficacy and safety study of carbon ion radiation therapy using 4 fractions for hepatocellular carcinoma (GUNMA0703)
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Medicine in general | 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,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
3-year local control rate
Key secondary outcomes
Overall survival
Progression free survival
Response rate
Acute toxicity(within 6 months)
Late toxicity(6 months or later)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) pathollogically or clinically diagnosed hepatocellular carcinoma.
2) Satellite nodules (daughter nodules) and/or tumor thrombus are contiguous or adjacent to the main tumor.
3) Tumor is measurable and tumor size is 10 cm or less than 10 cm.
4) Absence of invasion to the main branch of portal vein, common hepatic duct, or inferior vena cava.
5) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition)
6) At least 4 weeks passed after the previous therapy of hepatectomy, local ablation therapy or TACE.
7) No other intrahepatic lesion or at least 2 years passed after the previous curative therapy to other intraheaptic lesions.
8) Perfomance status of the patient is from 0 to 2.
9) Child-Pugh score of the patient is from 5 points to 9 points.
10) 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 was adjacent to the target lesion.
3) Patients with any other active malignancies.
4) Patient with severe comorbidity.
Target sample size
35
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@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
| 2016 | Year | 01 | Month | 14 | 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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
Study design:Prospective cohort study
Recruitment of patients: All patients who meet all inclusion criteria and not meet any exclusion criteria with hepatocellular carcinoma treated by heavy-ion particle therapy in Gunma university Heavy ion medical center. Patients who had been included into other clinical trials were excluded.
Management information
Registered date
| 2016 | Year | 01 | Month | 14 | Day |
Last modified on
| 2018 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023750
