UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020596 |
|---|---|
| Receipt number | R000023097 |
| Scientific Title | Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies |
| Date of disclosure of the study information | 2016/01/18 |
| Last modified on | 2020/07/21 14:07:38 |
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Basic information
Public title
Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies
Acronym
Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies
Scientific Title
Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies
Scientific Title:Acronym
Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies
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 proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies in a multicenter study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
3-year overall survival rate
Key secondary outcomes
1) 3-year progression free survival rate
2) 3-year local control rate
3) incidence of adverse events
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Proton beam therapy
A total dose of 66GyE (RBE=1.1) in 10 fractions (5 fractions/week)
For tumors within 2cm of the ports hepatic or gastrointestinal tract, a total dose of 72.6 GyE (RBE=1.1) in 22 fractions (5 fractions/week)
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) Pathologically proven or Radiologically diagnosed hepatocellular carcinoma (HCC) on dynamic CT or dynamic MRI within 28 days before registration
2) No prior treatment for HCC
3) Solitary HCC without extrahepatic lesions on chest and abdominal CT within 28 days before registration
4) Measurable tumor on dynamic CT or dynamic MRI within 28 days before registration and maximum tumor diameter <= 12 cm in the axial plane
5) Absence of invasion of the main trunk and/or major branches of the portal vein and the bile duct, or the inferior vena cava
6) No contact with the gastrointestinal tract
7) Unsuitable for resection or liver transplantation judged by a multidisciplinary meeting, prediction of severe deterioration in liver function after hepatic resection based on ICG R15, 99mTc-GSA scintigraphy, or CT volumetry
8) Unsuitable or difficult to undergo local ablative therapies judged by a multidisciplinary meeting
9) Eastern Cooperative Oncology Group (ECOG) Performance Status is 0, 1 or 2 within 14 days before registration
10) Liver function of Child-Pugh class A within 14 days before registration
11) Absence of uncontrolled pleural effusion or ascites within 28 days before registration
12) Vital organ functions (listed below) are preserved within 14 days before registration
WBC count >= 1,500/mm3; hemoglobin level >= 7.0 g/dL; platelet count >= 30,000/mm3; total bilirubin <= 3.0 mg/dL; sGOT (AST) and sGPT (ALT) < 5.0 x upper limit of normal
13) Age 20-years old or over at the time of obtaining the consent form
14) Given written informed consent to this study
Key exclusion criteria
1) With other malignancies (simultaneous double cancer and heterochronic double cancer with disease-free time within 5 years), excluding lesions equivalent to carcinoma-in-situ or submucosal carcinoma
2) With esophageal or gastric varices at high risk for rupture within 28 days before registration
3) With active infection requiring systemic therapy
4) With a fever of 38 degrees Celsius or more
5) With cardiac infarction or unstable angina within 6 months before registration
6) With interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema
7) Allergic to radiation
8) Considered that participation in this trial is difficult due to psychiatric symptoms or psychosis
9) Females who are pregnant, breast-feeding, within 28 days postpartum or have a possibility of conception
10) Considered that participation in this trial is difficult because of psychiatric symptoms or psychosis
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Shirato |
Organization
Hokkaido University Hospital
Division name
Department of Radiation Oncology
Zip code
060-8648
Address
North 14 West 5, Kita-Ku, Sapporo, Hokkaido
TEL
011-706-5977
shirato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Katoh |
Organization
Hokkaido University Hospital
Division name
Department of Radiation Oncology
Zip code
060-8648
Address
North 14 West 5, Kita-Ku, Sapporo, Hokkaido
TEL
011-706-5977
Homepage URL
noriwokatoh@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED(Japan)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Clinical Research Review Board
Address
North 14 West 5, Kita-Ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.ac.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 | 01 | Month | 18 | 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
30
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
Terminated
Date of protocol fixation
| 2016 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 22 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 21 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 08 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 16 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023097
