UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026561 |
|---|---|
| Receipt number | R000030493 |
| Scientific Title | A phase II study of carbon-ion radiotherapy for patients with hepatocellular carcinoma developing multiple lesions or complications |
| Date of disclosure of the study information | 2017/03/16 |
| Last modified on | 2023/12/27 11:53:37 |
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Basic information
Public title
A phase II study of carbon-ion radiotherapy for patients with hepatocellular carcinoma developing multiple lesions or complications
Acronym
Carbon-ion radiotherapy for multiple lesions of hepatocellular carcinoma (iROCK-1604LI)
Scientific Title
A phase II study of carbon-ion radiotherapy for patients with hepatocellular carcinoma developing multiple lesions or complications
Scientific Title:Acronym
Carbon-ion radiotherapy for multiple lesions of hepatocellular carcinoma (iROCK-1604LI)
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of carbon-ion radiotherapy for patients with multiple hepatocellular carcinoma or those with complications
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Three-year local control rate
Key secondary outcomes
1) Three-year overall survival
2) Three-year disease-specific survival
3) Adverse event rate
4) 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
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Carbon-ion radiotherapy consisting of two fractions of 48.0 Gy(RBE) in total or 4 fractions of 60.0 Gy(RBE) in total
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) Patients clinically diagnosed as hepatocellular carcinoma with abdominal dynamic CT or MRI showing hyperdense lesion at early phase and hypodense at delayed phase, or those diagnosed with histopathology
2) Within three lesions of uncontrolled hepatocellular carcinoma
3) No extrahepatic lesion, except for lesion which can be treated within single field of irradiation such as lymph nodes at hepatic portal region or around celiac trunk
4) Measurable target lesion
5) No invasion of main portal vein, common bile duct or inferior vena cava
6) 20 years old or more at registration of this trial
7) 0 to 2 of ECOG performance status before registration
8) A or B of Child-Pugh classification (Score 9 or below) before registration
9) No ascites or pleural fluid which is difficult to treat
10) Fulfilled with all of the following criteria of clinical laboratory tests taken within 14 days before trial registration
(a) Between 1,500 /mm3 or more, and, 10,000 /mm3 or less of white blood cell count
(b) 30,000 /mm3 or more of platelet count
(c) 7.0 g/dL or more of hemoglobin concentration
(d) 3.0 mg/dL or less of total serum bilirubin
11) Expected improvement of survival or symptom after treatment in this trial
12) Not eligible for other clinical trials on carbon-ion radiotherapy in Kanagawa Cancer Center
13) Written consent obtained
Key exclusion criteria
1) Patients who are expected within one year of survival even after treatment of hepatocellular carcinoma
2) Past history of radiotherapy for target lesion
3) Patients with gastroesophageal varix which should be treated
4) Patients with 38 C or more of fever at registration of this trial or with infection which requires systemic treatment
5) Pregnant, possibly pregnant, within 28 days after delivery or breast-feeding female
6) Patients who are difficult to be participated in this trail due to psychological diseases, intractable heart or lung diseases at registration
7) Patients who are not suitable to be participated due to medical reason evaluated by primary physician
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, JAPAN
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, JAPAN
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
地方独立行政法人神奈川県立病院機構 神奈川県立がんセンター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 16 | 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
41
Results
This study confirmed safety and efficacy comparable to those reported from prior facilities.
Results date posted
| 2023 | Year | 12 | Month | 27 | 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 | 12 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2025 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2026 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030493
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