UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037241 |
|---|---|
| Receipt number | R000042456 |
| Scientific Title | Safety and efficacy after multiple carbon-ion radiotherapy for patients with hepatocellular carcinoma |
| Date of disclosure of the study information | 2019/09/02 |
| Last modified on | 2023/01/07 15:10:26 |
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Basic information
Public title
Safety and efficacy after multiple carbon-ion radiotherapy for patients with hepatocellular carcinoma
Acronym
Multiple carbon-ion radiotherapy for patients with hepatocellular carcinoma
Scientific Title
Safety and efficacy after multiple carbon-ion radiotherapy for patients with hepatocellular carcinoma
Scientific Title:Acronym
Multiple carbon-ion radiotherapy for patients with hepatocellular carcinoma
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy after multiple carbon-ion radiotherapy for patients with hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety after multiple carbon-ion radiotherapy for liver
Key secondary outcomes
Efficacy after multiple carbon-ion radiotherapy for hepatocellular carcinoma
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
| Device,equipment |
Interventions/Control_1
Carbon-ion radiotherapy
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. Biopsy or radiologically proven HCC
2. Measurable lesion on imaging.
3. Eastern Cooperative Oncology Group (ECOG) performance Status 0-2
4. Those patients treated with 2 or 4 fractions of hypofractionated CIRT
5. Tumours which were more than 5mm away from the tubular GI structures
Key exclusion criteria
1. An estimated life expectancy of less than 6 months.
2. Presence of digestive tract within the clinical target volume
3. Medical comorbidities precluding safe administration of re cIRT.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Goro |
| Middle name | |
| Last name | Kasuya |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
QST hospital
Zip code
263-8555
Address
Anagawa, Inage Ward, Chiba-City
TEL
043-206-3306
kasuya.goro@qst.go.jp
Public contact
Name of contact person
| 1st name | Goro |
| Middle name | |
| Last name | Kasuya |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
QST hospital
Zip code
263-8555
Address
Anagawa, Inage Ward, Chiba-City
TEL
043-206-3306
Homepage URL
kasuya.goro@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
National Institutes for Quantum and Radiological Science and Technology
Address
Anagawa, Inage Ward, Chiba-City
Tel
043-206-4706
helsinki@qst.go.jp
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
| 2019 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042456
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042456
Number of participants that the trial has enrolled
60
Results
Delivering re-irradiation for recurrent hepatocellular carcinoma is challenging because of possible risk of radiation induced liver disease. Here, we evaluated the safety and efficacy of repeated hypofractionated carbon-ion radiotherapy in 60 patients of recurrent hepatocellular carcinoma using 2 or 4 fractions.Repeated extremely hypofractionated carbon-ion radiotherapy proved to be safe with promising outcomes in this study.
Results date posted
| 2023 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All 60 patients received second session of CIRT, and 3rd, 4th and 5th sessions of CIRT were received by 7, 3 and 1 patients, respectively. The median total dose was 48Gy (RBE) for all the sessions.
Participant flow
This is a retrospective analysis of case records of 60 patients repeatedly irradiated with 2 or 4 fractions of CIRT for HCC from 2000-2017.
Adverse events
On both univariate and multivariate analyses, CP class B or worse before 2nd session remained the significant prognostic factor of OS (p=0.003) calculated from 2nd session.
Outcome measures
None of the patients developed classic or non-classic radiation induced liver disease even after repeated CIRT including 20 patients with infield recurrence after 1st session, although Child Pugh (CP) score was elevated 2 or more in 10 patients within 6 months. After 2nd session of CIRT, 1- and 2-year local control (LC) rates were 94.0% (95% CI:82.4-98.0%) and 91.2% (95% CI:77.9-96.6%), respectively. After 2nd session, the median overall survival (OS) was 22.0 months (95% CI: 19.0-35.0 months) and 1- and 2-year OS rates were 85.8% (95%CI: 73.6-92.6%) and 44.8% (95% CI-31.3-57.4%), respectively. Out of 20 patients who developed infield recurrences after 1st session, eventually 16 of them could escape any infield recurrence with 2-year LC and OS rates of 77.0% (95% CI: 43.2-92.2%) and 44.6% (95% CI: 20.4-66.4%), respectively, after 2nd session with a median follow up of 19 months.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 07 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042456
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