UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004106 |
|---|---|
| Receipt number | 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 19:21:32 |
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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
| Obstetrics 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
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
Sponsor or person
Institute
Dept. of radiation oncology,Osaka University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004936
