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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033898
Receipt No. R000036774
Scientific Title Prospective assessment for the development of radiation-induced lung injury after stereotactic radiotherapy
Date of disclosure of the study information 2018/08/27
Last modified on 2019/02/24

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Basic information
Public title Prospective assessment for the development of radiation-induced lung injury after stereotactic radiotherapy
Acronym Radiation-induced lung injury after stereotactic radiotherapy
Scientific Title Prospective assessment for the development of radiation-induced lung injury after stereotactic radiotherapy
Scientific Title:Acronym Radiation-induced lung injury after stereotactic radiotherapy
Region
Japan

Condition
Condition Primary lung cancer
Classification by specialty
Pneumology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To perform prospective assessments for radiation-induced lung injury, hypoxia and dyspnea which are main adverse event after stereotactic radiotherapy for lung cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The grading of radiation-induced lung injury, hypoxia and dyspnea at baseline, 1 month, 4 month and 12 month after stereotactic radiotherapy.
Key secondary outcomes The assessment of lung function using spirometry, perfusion CT, 4-D CT, BMI and fat-free mass index at baseline, 1 month, 4 months and 12 month after stereotactic radiotherapy.

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 1.Patients who are scheduled for stereotactic radiotherapy for primary lung cancer.
2.tumor diameter:5 cm >=
Key exclusion criteria 1. Patients who are not suitable for using a contrast medium because of renal function or allergy.
2. Pregnant or lactating woman, likelihood of pregnancy
3. Radiation oncologist judged that the patient was not suitable for stereotactic radiotherapy
4. Critical mental disturbance
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaya Yamamoto
Organization Tohoku University Graduate School of Medicine
Division name Department of Radiuation Oncology
Zip code
Address Seiryo-machi 1-1, Aoba-ku, Sendai
TEL +81-22-717-7312
Email t.yamamoto@rad.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name See above
Organization See above
Division name See above
Zip code
Address See above
TEL +81-22-717-7312
Homepage URL
Email t.yamamoto@rad.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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
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 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 Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients who are scheduled for stereotactic radiotherapy for primary lung cancer was assessed for radiation-induced lung injury, hypoxia, dyspnea, spirometry, perfusion CT, 4-D CT, BMI and fat-free mass index at baseline, 1 month, 4 months and 12 months after stereotactic radiotherapy.

Management information
Registered date
2018 Year 08 Month 25 Day
Last modified on
2019 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036774

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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