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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036061
Receipt No. R000040344
Scientific Title Durvalumab for patients who had mild radiation pneumonitis after concurrentchemoradiotherapy.
Date of disclosure of the study information 2019/03/01
Last modified on 2019/03/01

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Basic information
Public title Durvalumab for patients who had mild radiation pneumonitis after concurrentchemoradiotherapy.
Acronym Durvalumab in patients who had radiation pneumonitis.
Scientific Title Durvalumab for patients who had mild radiation pneumonitis after concurrentchemoradiotherapy.
Scientific Title:Acronym Durvalumab in patients who had radiation pneumonitis.
Region
Asia(except Japan)

Condition
Condition NSCLC
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The efficay and safety of durvalumab in patients who had grade 1 radiation pneumonitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety
Key secondary outcomes Progression free survival

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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Stage III NSCLC
patients who had response of CCRT
Patients who had grade 1 pneumonitis within 42 days after CCRT
Patients who started durvalumab within 42 days after CCRT
PS0-1
Key exclusion criteria Patients who do not meet the criteria above
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daichi Fujimoto
Organization Kobe city medical center general hospotal
Division name Division of respiratory medicine
Zip code
Address minatojima-minamimachi, Kobe
TEL 078-302-4321
Email daichi@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daichi Fujimoto
Organization Kobe city medical center general hospotal
Division name Division of respiratory medicine
Zip code
Address minatojima-minamimachi, Kobe
TEL 078-302-4321
Homepage URL
Email daichi@kcho.jp

Sponsor
Institute Kobe city medical center general hospital
Institute
Department

Funding Source
Organization Astrazeneca
Organization
Division
Category of Funding Organization Profit organization
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 神戸市立医療センター中央市民病院 
兵庫医科大学病院 呼吸器内科 
千葉大学大学医学部付属病院
神戸低侵襲がん医療センター 呼吸器腫瘍内科
大阪国際がんセンター 
近畿中央胸部疾患センター 
大阪はびきの医療センター 肺腫瘍内科 
兵庫県立尼崎総合医療センター 呼吸器内科 
公益財団法人大原記念倉敷中央医療機構 倉敷中央病院 呼吸器内科 
市立伊丹病院 呼吸器内科 
国立病院機構刀根山病院 呼吸器腫瘍内科 
大阪急性期・総合医療センター 呼吸器内科

Other administrative information
Date of disclosure of the study information
2019 Year 03 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
2019 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2019 Year 03 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 prospective multicenter observational trial

Management information
Registered date
2019 Year 03 Month 01 Day
Last modified on
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040344

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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