UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020444 |
|---|---|
| Receipt number | R000023620 |
| Scientific Title | Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER) |
| Date of disclosure of the study information | 2016/01/10 |
| Last modified on | 2020/07/09 09:16:28 |
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Basic information
Public title
Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)
Acronym
Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)
Scientific Title
Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)
Scientific Title:Acronym
Multi-center clinical trial of a Carbon-ion radiation therapy for unresectable and local therapy unsuitable hepatocellular carcinoma (J-CROS 1505 LIVER)
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 efficacy and safety of the carbon-ion radiation therapy for hepatocellular carcinoma in multi-institutional setting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival (Three-year overall survival)
Key secondary outcomes
Progression free survival (Three-year), Local progression free survival (Three-year), Adverse event, Incidence of radiation-induced liver disease(RILD)
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
60 Gy(RBE) / 4 fractions
60 Gy(RBE) / 12 fractions (adjacent to organ at risk)
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) Histologically or clinically diagnosed primary hepatocellular carcinoma.
2) Untreated and absence of previous local therapy.
3) Solitary tumor without extrahepatic lesions.
4) The tumor is measurable and tumor size is less than 12 cm.
5) Absence of major portal vein and/or hepatic vein.
6) The tumor is in contact with the alimentary tract.
7) Unfit for resection or liver transplantation.
8) Unfit for percutaneous tumor ablation.
9) ECOG PS: 0-2.
10) Child-Pugh score of the patient is from 5 points to 9 points.
11) Absence of uncontrolled ascites and/or pleural effusion.
12) 20-year-old or older.
13) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.
Key exclusion criteria
1) Patients with any other active malignancies.
2) Having esophageal varices which are at great risk of bleeding
3) Having active infectious diseases
4) Having a fever greater than 38 degrees Celsius.
5) Having myocardial infarction or angina pectoris within 6 months.
6) Having interstitial pneumonitis, pulmonary fibrosis or severe respiratory disease such as pulmonary emphysema.
7) Having radiation hypersensitivity.
8) Associated with mental illness or manifestation complicating study participation.
9) Being pregnant or possible conception.
10) Miscellaneous inappropriate conditions judged by physicians.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ohno |
Organization
Gunma University Hospital
Division name
Department of radiation oncology
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-8378
tnakano@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Shibuya |
Organization
Gunma University
Division name
Heavy Ion Medical Center
Zip code
371-8511
Address
3-39-15 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
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa, Maebashi, Gunma
Tel
027-220-7111
nakamurt@gunma-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCT1032200036
Org. issuing International ID_1
jRCT
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 | 10 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | 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
| 2016 | Year | 01 | Month | 05 | Day |
Last modified on
| 2020 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023620
