UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021558 |
|---|---|
| Receipt number | R000024858 |
| Scientific Title | A Phase II Clinical Trial of Carbon-Ion Therapy for Hepatocellular Carcinoma |
| Date of disclosure of the study information | 2016/03/24 |
| Last modified on | 2023/12/26 11:12:07 |
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Basic information
Public title
A Phase II Clinical Trial of Carbon-Ion Therapy for Hepatocellular Carcinoma
Acronym
Carbon-ion radiotherapy for hepatocytecarcinoma (iROCK-1601LI)
Scientific Title
A Phase II Clinical Trial of Carbon-Ion Therapy for Hepatocellular Carcinoma
Scientific Title:Acronym
Carbon-ion radiotherapy for hepatocytecarcinoma (iROCK-1601LI)
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 carbon-ion radiotherapy for patients with hepatocellular carcinoma in Kanagawa Cancer Center
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Local control rate at 3 years
Key secondary outcomes
1) Disease-specific survival
2) Overall survival
3) Adverse event rate
4) Event rate for 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
| Device,equipment |
Interventions/Control_1
Carbon-ion radiotherapy (C-RT)
A total dose of 48.0 Gy(RBE)/2Fr or 60.0 Gy(RBE)/4Fr will be administered. C-RT with 60Gy(RBE)/12Fr will be performed if the subject shows the distance equal to or less than 10mm between main portal vein, the first branch of portal vein, gastrointestinal duct and the lesion targeted.
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) Clinically diagnosed as hepatocellular carcinoma (HCC) by dynamic CT or MRI, or histologically diagnosed HCC
2) No past history of radiotherapy for target lesion
3) Single lesion without extrahepatic lesions or HCC with controlled lesions except for the target
4) Measurable lesion on clinical image studies
5) No invasion for main trunk of the portal vein, common bile duct or inferior vena cava
6) 20 years or older of the age at informed consent
7) 0 or 2 of ECOG performance status
8) A or B of Child-Pugh Classification (Score 9 or below)
9) No pleural effusion or ascites which is not controlled
10) Clinical laboratory data is fulfilled with the following criteria
(a) 1,500 /mm3 or higher and 10,000/mm3 or less of white blood cells on complete blood count
(b) 30,000 /mm3 or higher of platelet count
(c) 7.0 g/dL or higher of hemoglobin
(d) 3.0 mg/dL or less of serum total bilirubin
11) Informed consent given with document
Key exclusion criteria
1) Active double cancer
2) Past history of radiotherapy for the target lesion
3) Patient with gastroesophageal varix should be treated
4) 38 degrees celsius or higher of fever, except for tumor fever, or infection which requires systemic therapy
5) Pregnant women, women who may become pregnant, women who deliver with 28 days or lactating women
6) Patient who is difficult to participate this study due to psychiatric condition, uncontrolled heart disease or severe pulmonary disease
7) Patient who is not suitable to participate this study in accordance with physician's examination
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name
Department of Carbon-ion Radiotherapy
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
hkatoh@kcch.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Katoh |
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name
Ion-beam Radiation Oncology Center
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
Homepage URL
hkatoh@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Kanagawa Cancer Center IRB
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
Tel
045-520-2222
clinical_trials@kcch.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
| 2016 | Year | 03 | Month | 24 | 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
26
Results
This study confirmed safety and efficacy comparable to those reported from prior facilities.
Results date posted
| 2023 | Year | 12 | Month | 26 | Day |
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
| 2016 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024858
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