UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031591
Receipt number 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 17:52:14

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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 or person

Institute

Keiyukai Sapporo Hospital

Institute

Department

Personal name



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

Value
https://center6.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