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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017886
Receipt No. R000020725
Scientific Title Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer.
Date of disclosure of the study information 2015/07/01
Last modified on 2019/06/15

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Basic information
Public title Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer.
Acronym Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer.
Scientific Title Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer.
Scientific Title:Acronym Phase II study of dynamic tumor tracking stereotactic body radiotherapy for liver cancer.
Region
Japan

Condition
Condition liver cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of the sterotactic body radiotherapy for liver cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Phase II

Assessment
Primary outcomes 2-year local control rate
Key secondary outcomes overall survival rate, progression free survival rate, local progression free survival rate, adverse event, severe adverse event, treatment accuracy, dose-volume index.

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
Other
Interventions/Control_1 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Clinically diagnosed primary or metastatic liver cancers less than 4, and with diameter between 1 to 5 cm.
2) No indication or refusal for surgical resection, radio frequency ablation.
4) ECOG Performance Status 0-2
5) The patients can raise their arms and keep supine position with about 30 minutes.
6) Respiratory movement is more than 10mm.
7) Written informed consent
Key exclusion criteria 1) History of radiation therapy to the site
2) Refractory pleural effusion or ascites
3) Esophageal varies with high risk of bleeding
4) Obviously active interstitial pneumonia or pulmonary fibrosis
5) Severe diabetes or collagen disease
6) Pregnant and lactating females
7) Severe mental disorder to participate in this study
8) Patients who are concluded to be inappropriate to participate in this study by their physicians
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Mizowaki
Organization Kyoto University
Division name Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3762
Email mizo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukinori Matsuo
Organization Kyoto University
Division name Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3762
Homepage URL
Email ymatsuo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 神戸市立医療センター中央市民病院(兵庫県) Kobe City Medical Center General Hospital
がん・感染症センター都立駒込病院(東京都) Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
京都桂病院(京都府) Kyoto Katsura Hospital
日本赤十字社和歌山医療センター(和歌山県)Japanese Red Cross Wakayama Medical Center

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 01 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
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 No longer recruiting
Date of protocol fixation
2015 Year 06 Month 02 Day
Date of IRB
2015 Year 07 Month 24 Day
Anticipated trial start date
2015 Year 07 Month 24 Day
Last follow-up date
2021 Year 03 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 12 Day
Last modified on
2019 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020725

Research Plan
Registered date File name
2019/06/15 肝臓追尾プロトコル_201808.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/06/15 AMED追尾多施設肝202006.xlsx


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