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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031591
Receipt No. R000036070
Scientific Title The volume effect of detectors for beam modeling of radiation treatment planning system and its impact on IMRT dose verification: The LDA-99SC versus the ion chamber.
Date of disclosure of the study information 2018/10/13
Last modified on 2018/03/05

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Basic information
Public title The volume effect of detectors for beam modeling of radiation treatment planning system and its impact on IMRT dose verification: The LDA-99SC versus the ion chamber.
Acronym The accuracy of IMRT dose verification by detectors used for beam modeling
Scientific Title The volume effect of detectors for beam modeling of radiation treatment planning system and its impact on IMRT dose verification: The LDA-99SC versus the ion chamber.
Scientific Title:Acronym The accuracy of IMRT dose verification by detectors used for beam modeling
Region
Japan

Condition
Condition Patients with head and neck cancer or prostate cancer who were treated with IMRT at Keiyukai Sapporo Hospital.
Classification by specialty
Surgery in general Oto-rhino-laryngology Urology
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the volume effect of beam modeling detectors on IMRT dose verification.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The selection of a detector for appropriate beam modeling (LDA99 vs. ion chamber)
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Twenty patients with head and neck cancer or prostate cancer receiving IMRT using Elekta Synergy Linac at Keiyukai Sapporo Hospital from January 2012.
Key exclusion criteria Head and neck cancer patients treated with 4MV X-ray beam.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuta kobayashi
Organization Keiyukai Sapporo Hospital
Division name Department of Radiation Oncology
Zip code
Address Kita1-1, Hondori 14, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL +81-11-863-2101
Email kool008madd@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Nobuo Hongo
Organization Keiyukai Sapporo Hospital
Division name Administrative office
Zip code
Address Kita1-1, Hondori 14, Shiroishi-ku, Sapporo, Hokkaido, Japan
TEL +81-11-863-2101
Homepage URL http://www.keiyukaisapporo.or.jp
Email nhongo@keiyukaisapporo.co.jp

Sponsor
Institute Keiyukai Sapporo Hospital
Institute
Department

Funding Source
Organization Keiyukai Sapporo Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 13 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 Enrolling by invitation
Date of protocol fixation
2012 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In radiation therapy strategies, the treatment planning system (TPS) is dispensable for simulate the absorbed dose distribution in patients is indispensable. The dose distribution is calculated using the beam model created from the beam profile that is unique to each Linac, but the model greatly differs depending on detector used for profile measurements. Particularly in intensity-modulated radiation therapy (IMRT) and stereotactic radiotherapy (SRT) that use many small irradiation fields, the difference in beam model has large influence on the dose calculation results, and it is necessary to select an appropriate detector to evaluate dose distribution accurately.

Management information
Registered date
2018 Year 03 Month 05 Day
Last modified on
2018 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036070

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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