UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020596
Receipt No. R000023097
Official scientific title of the study 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 2016/06/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Proton beam therapy for hepatocellular carcinoma unsuitable for surgery or local ablative therapies
Title of the study (Brief title) 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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Hiroki Shirato
Organization Hokkaido University Graduate School of Medicine
Division name Department of Radiation Medicine
Address North 15 West 7, Kita-Ku, Sapporo, Hokkaido
TEL +81-11-706-5977
Email shirato@med.hokudai.ac.jp

Public contact
Name of contact person Norio Katoh
Organization Hokkaido University Graduate School of Medicine
Division name Department of Radiation Medicine
Address North 15 West 7, Kita-Ku, Sapporo, Hokkaido
TEL +81-11-706-5977
Homepage URL
Email noriwokatoh@med.hokudai.ac.jp

Sponsor
Institute Department of Radiation Medicine, Hokkaido University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 05 Month 12 Day
Anticipated trial start date
2016 Year 06 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2016 Year 01 Month 16 Day
Last modified on
2016 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023097


For inquiries about the use of UMIN clinical trial registration system, use this contact form .Fort other inquiries, use this contact form