UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020441 |
|---|---|
| Receipt number | R000023610 |
| Scientific Title | Multicenter retrospective observational study of carbon-ion radiation therapy for hepatocellular carcinoma (J-CROS 1504) |
| Date of disclosure of the study information | 2016/01/05 |
| Last modified on | 2016/01/14 16:19:54 |
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Basic information
Public title
Multicenter retrospective observational study of carbon-ion radiation therapy for hepatocellular carcinoma (J-CROS 1504)
Acronym
Multicenter retrospective observational study of carbon-ion radiation therapy for hepatocellular carcinoma (J-CROS 1504)
Scientific Title
Multicenter retrospective observational study of carbon-ion radiation therapy for hepatocellular carcinoma (J-CROS 1504)
Scientific Title:Acronym
Multicenter retrospective observational study of carbon-ion radiation therapy for hepatocellular carcinoma (J-CROS 1504)
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the safety and efficacy of carbon-on radiation therapy in Japanese institutions for hepatocellular carcinoma retrospectively
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Local control rate, Acute and rate toxicity (within 3 months and 3 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) All lesions were included in the single radiation field.
3) Treated by hypofractionated treatment course.(Patients treated by more than 4 fractions are analysed separately)
4) Tumor size is Measurable.
5) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition)
6) Patients without any other active malignancies.
7) Absence of uncontrolled ascites
8) Child-Pugh score of the patient is from 5 points to 9 points.
9) Perfomance status of the patient is from 0 to 2.
10) Written informed concent is obtained.
Key exclusion criteria
1) History of radiation therapy to the lesion of interest.
2) Presence of major portal or hepatic vein invasion.
3) History of hepatocellular carcinoma in except for the lesion of interest.
4) Patient with severe comorbidity.
Target sample size
250
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
Japan Carbon-ion Radiation Oncology Study Group (J-CROS)
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
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 | 05 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | 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: Nationwide multi-institutional retrospective observational study (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 from April 1995 to November 2014 in four institutions which could provide carbon-ion radiation therapy in Japan. Patients who had been included into other clinical trials were excluded.
Management information
Registered date
| 2016 | Year | 01 | Month | 05 | Day |
Last modified on
| 2016 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023610
