UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013197
Receipt No. R000015387
Scientific Title Safety test of radiotherapy with Proton beam therapy system
Date of disclosure of the study information 2014/02/21
Last modified on 2017/04/13

* 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
Public title Safety test of radiotherapy with Proton beam therapy system
Acronym Safety test of Proton beam therapy
Scientific Title Safety test of radiotherapy with Proton beam therapy system
Scientific Title:Acronym Safety test of Proton beam therapy
Region
Japan

Condition
Condition Solid tumor
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety of radiotherapy with proton beam therapy system
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Incidence of the early phase adverse invent induced by radiotherapy using Proton beam therapy system
Key secondary outcomes 1) changes in tumor volume
2) changes in tumor marker
3) changes in subjective symptoms or QOL

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 Proton beam therapy system
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with pathologically proved malignant tumor, or pathologically proved benign disease that the effectiveness of X-ray treatment was verified
2) Patients with clinically evident malignant disease
3) Patients with clinically benign disease that the effectiveness of X-ray treatment was verified
4) A well-informed written consent was obtained from the patient (and the person with parental authority if the patient was younger than age 20 years)
5) PS is 0-3 in the criteria of ECOG
Key exclusion criteria 1) with serious active infections in the irradiated sites
2) with severe diabetes that uncontrolled, or treated by using insulin
3) with severe heart disease, or some serious complications, i.e., SLE, Scleroderma, interstitial pneumonia
4) pregnant or likely to be
5) considered that participation in this trial is difficult because of psychiatric symptoms or psychosis
6) the proposed radiation treatment site had been given tolerance dose in the past
7) Patient who cannot be held rest for about 30 minutes, except the patient younger than 20 years old who can be held rest under sedation
8) weight over 135kg
9) unsuitable for enrollment judged by principal investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Shirato
Organization Hokkaido University Graduate School of Medicine
Division name Department of Radiation Medicine
Zip code
Address North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL +81-11-706-5977
Email shirato@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Shimizu
Organization Hokkaido University Graduate School of Medicine
Division name Department of Radiation Oncology
Zip code
Address North 15 West 7, Kita-Ku, Sapporo, Hokkaido, Japan
TEL +81-11-706-5977
Homepage URL
Email sshing@med.hokudai.ac.jp

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

Funding Source
Organization the Cabinet Office, Government of Japan and the Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization Other
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 北海道大学病院

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 21 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 Terminated
Date of protocol fixation
2014 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 19 Day
Last modified on
2017 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015387

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.