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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029724
Receipt No. R000033965
Scientific Title Prospective study on adaptive radiotherapy using treatment room CT
Date of disclosure of the study information 2018/01/01
Last modified on 2019/04/30

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Basic information
Public title Prospective study on adaptive radiotherapy using treatment room CT
Acronym Prospective study on adaptive radiotherapy using treatment room CT
Scientific Title Prospective study on adaptive radiotherapy using treatment room CT
Scientific Title:Acronym Prospective study on adaptive radiotherapy using treatment room CT
Region
Japan

Condition
Condition Pharyngeal & Laryngeal cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In this clinical trial, the treatment room CT of radiotherapy patients is deformed on Eclipse, the volumetric change and the position change amount of the target and the risk organs are measured, the dose change is confirmed, and the optimal timing of the re-treatment plan is measured It is aimed at.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Timing at which dose change occurs in treatment room CT (week number)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 We will shoot by expanding the shooting range in the treatment room CT not to the conventional 16 cm, but to 32 cm including the entire irradiation range.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with pharyngeal / laryngeal cancer with diagnosis of malignant tumor by histopathological examination
2) Patients who undergo radical chemoradiotherapy or radiotherapy alone (60-70 Gy / 30-35 fractions) to the macroscopic tumor volume of the primary tumor
3) Performance status (ECOG): 0 to 2
4) Patients whose age at registration is 20 years or over, 80 years old or younger
5) About participation in the study Informed consent is obtained from the patient himself.
Key exclusion criteria 1) Patients with radiation therapy alone
2) Patients judged inappropriate by the attending physician
3) Patients who took only less than five shots from the treatment cen- tory CT in the treatment room.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yasumasa
Middle name
Last name Nishimura
Organization Kindai University Faculty of Medicine
Division name Department of Radiation Oncology
Zip code 589-8511
Address 377-2, Ohno-Higashi, Osaka-Sayama, Osaka
TEL 072-366-0221
Email ynishi@med.kindai.ac.jp

Public contact
Name of contact person
1st name Kazuki
Middle name
Last name Ishikawa
Organization Kinndai University Faculty of Medicine
Division name Department of Radiation Oncology
Zip code 589-8511
Address 377-2, Ohno-Higashi, Osaka-Sayama, Osaka
TEL 072-366-0221
Homepage URL
Email k-ishi@med.kindai.ac.jp

Sponsor
Institute Kindai University
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kindai University Faculty of Medicine Ethics Committee
Address 377-2, Osaka-sayama, Osaka, Japan
Tel 072-366-0221 (ext. 3756)
Email zizen@med.kinda.ac.jp

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 01 Month 01 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
2017 Year 12 Month 16 Day
Date of IRB
2017 Year 11 Month 22 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2019 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 26 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033965

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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