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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004106
Receipt No. R000004936
Scientific Title Megavoltage cone-beam computed tomography (CT) dose-integrated intensity modulated radiation therapy (IMRT) for visualization of soft tissue
Date of disclosure of the study information 2010/08/27
Last modified on 2010/08/26

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Basic information
Public title Megavoltage cone-beam computed tomography (CT) dose-integrated intensity modulated radiation therapy (IMRT) for visualization of soft tissue
Acronym Megavoltage cone-beam CT dose-integrated IMRT for visualization of soft tissue
Scientific Title Megavoltage cone-beam computed tomography (CT) dose-integrated intensity modulated radiation therapy (IMRT) for visualization of soft tissue
Scientific Title:Acronym Megavoltage cone-beam CT dose-integrated IMRT for visualization of soft tissue
Region
Japan

Condition
Condition Malignant neoplasms that can be treated with IMRT, including locally advanced prostate, head and neck, or gynecologic cancers
Classification by specialty
Obsterics and gynecology Oto-rhino-laryngology Urology
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine an appropriate schedule for geometrical verification and the bet set-up margin by investigating the precision and the accuracy of bone matching and soft tissue matching.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To calculate systematic and random error between images of treatment planning CT and cone-beam CT.
Key secondary outcomes

Base
Study type Observational

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Pathologically proven malignant neoplasms that can be treated with IMRT, including locally advanced prostate, head and neck, or gynecologic cancers.
Age;20>
informed consent
Key exclusion criteria Age;20<
Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Yoshioka
Organization Osaka University Hospital
Division name Dept. of radiation oncology
Zip code
Address 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
TEL 06-6879-3482
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shoichi Fukuda
Organization Osaka University Hospital
Division name Dept. of radiation oncology
Zip code
Address 2-2 Yamada-oka, Suita 565-0871, Osaka, Japan
TEL
Homepage URL
Email

Sponsor
Institute Dept. of radiation oncology,Osaka University Hospital
Institute
Department

Funding Source
Organization Dept. of radiation oncology,Osaka University 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
2010 Year 08 Month 27 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 Open public recruiting
Date of protocol fixation
2010 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Trained radiation oncologists perform geometrical verification once a week and modify the set-up position if necessary.

Management information
Registered date
2010 Year 08 Month 26 Day
Last modified on
2010 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004936

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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