UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036061 |
|---|---|
| Receipt number | 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 | 2023/09/26 10:04:02 |
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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 | Daichi |
| Middle name | |
| Last name | Fujimoto |
Organization
Kobe city medical center general hospotal
Division name
Division of respiratory medicine
Zip code
650-0047
Address
minatojima-minamimachi, Kobe
TEL
078-302-4321
daichi@kcho.jp
Public contact
Name of contact person
| 1st name | Daichi |
| Middle name | |
| Last name | Fujimoto |
Organization
Kobe city medical center general hospotal
Division name
Division of respiratory medicine
Zip code
650-0047
Address
minatojima-minamimachi, Kobe
TEL
078-302-4321
Homepage URL
daichi@kcho.jp
Sponsor or person
Institute
Kobe city medical center general hospital
Institute
Department
Personal name
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
Kobe city medical center general hospital
Address
minatojima-minamimachi, Kobe
Tel
078-302-4321
rinken@kcho.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
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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | Day |
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
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040344
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| Registered date | File name |
| Research case data | |
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