UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051189 |
|---|---|
| Receipt number | R000058382 |
| Scientific Title | Single-arm meta-analysis of EGFR-TKI rechallenge or continue treatment |
| Date of disclosure of the study information | 2023/05/29 |
| Last modified on | 2024/04/08 19:54:42 |
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Basic information
Public title
Single-arm meta-analysis of EGFR-TKI rechallenge or continue treatment
Acronym
Single-arm meta-analysis of EGFR-TKI rechallenge or continue treatment
Scientific Title
Single-arm meta-analysis of EGFR-TKI rechallenge or continue treatment
Scientific Title:Acronym
Single-arm meta-analysis of EGFR-TKI rechallenge or continue treatment
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
EGFR mutated non-small cell lung cancer patients
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Identified the possibility of EGFR-TKI rechallenge
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
continue rate of EGFR-TKI
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with EGFR-mutation
Key exclusion criteria
without rechallenge
others
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Fumihiro |
| Middle name | |
| Last name | Kashizaki |
Organization
Department of Respiratory Minami kyousai Hospital
Division name
Department of Respiratory Minami kyousai Hospital
Zip code
236-0037
Address
1-21-1 Mutsuura Higashi, Kanazawa Ward, Yokohama City, Kanagawa
TEL
045-782-2101
chibitantan2525@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Fumiiro |
| Middle name | |
| Last name | Kashizaki |
Organization
Department of Respiratory Minami Kyousai Hospital
Division name
Department of Respiratory Minami Kyousai Hospital
Zip code
225
Address
1-21-1 Mutsuura Higashi, Kanazawa Ward, Yokohama City, Kanagawa
TEL
0457822101
Homepage URL
chibitantan2525@yahoo.co.jp
Sponsor or person
Institute
Department of Respiratory Minami Kyousai Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Minami Kyousai Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Respiratory Minami Kyousai Hospital
Address
1-21-1 Mutsuura Higashi, Kanazawa Ward, Yokohama City, Kanagawa
Tel
045-782-2101
chibitantan2525@yahoo.co.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
| 2023 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S1525730423001912?dgcid=author
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37932180/
Number of participants that the trial has enrolled
690
Results
The initial EGFR-TKI-induced ILD rate was 13.6% (95% confidence interval [CI]:6.4-20.9). Readministration rate of EGFR-TKI after onset of EGFR-TKI-induced ILD was 40.2% (95% CI: 26.7-53.7). The successful readministration rate of EGFR-TKIs after onset of EGFR-TKI-induced ILD was 81.9% (95% CI: 73.8-90.0). Successful rate of EGFR-TKI readministration in patients with Grade 2 or higher adverse events post initial EGFR-TKI therapy was 76.1% (95% CI: 55.6-96.6).
Results date posted
| 2023 | Year | 11 | Month | 28 | Day |
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
| 2023 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 21 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Not available
Management information
Registered date
| 2023 | Year | 05 | Month | 29 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058382
