UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042975 |
|---|---|
| Receipt number | R000049065 |
| Scientific Title | A multi-institutional retrospective study of dacomitinib in rechallenge setting for patients with EGFR mutation (TOPGAN2020-02) |
| Date of disclosure of the study information | 2021/01/15 |
| Last modified on | 2022/07/15 05:10:50 |
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Basic information
Public title
A multi-institutional retrospective study of dacomitinib in rechallenge setting for patients with EGFR mutation (TOPGAN2020-02)
Acronym
TOPGAN2020-02
Scientific Title
A multi-institutional retrospective study of dacomitinib in rechallenge setting for patients with EGFR mutation (TOPGAN2020-02)
Scientific Title:Acronym
TOPGAN2020-02
Region
| Japan |
Condition
Condition
non-small cell lung cancer(EGFR mutation +)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the clinical coarse, the efficacy and safety, of dacomitinib for patients with EGFR mutation positive non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the clinical coarse, the efficacy and safety, of dacomitinib for patients with EGFR mutation positive non-small cell lung cancer
PFS
Key secondary outcomes
OS
ORR
AE
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who received dacomitinib therapy as rechallenge setting between January 2019 and October 2020
Key exclusion criteria
None
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | MAKOTO |
| Middle name | |
| Last name | NISHIO |
Organization
The Cancer Institute Hospital of JFCR
Division name
respiratory medicine
Zip code
135-8550
Address
31-8-3 Ariake, Koutou-ku,Tokyo
TEL
03-3520-0111
ganken-net@umin.ac.jp
Public contact
Name of contact person
| 1st name | HISASHI |
| Middle name | Tanaka |
| Last name | TANAKA |
Organization
Hirosaki University garduate school of medicine
Division name
Respiratory medicine
Zip code
0368562
Address
Zaifu-cho
TEL
0172395468
Homepage URL
xyghx335@gmail.com
Sponsor or person
Institute
TOPGAN group
Institute
Department
Personal name
Funding Source
Organization
TOPGAN group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University
Address
5, zaifu -cho, HIrosaki, Aomori, 036-8562
Tel
0172-33-5111
rinri@hirosaki-u.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
| 2021 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35415873/
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35415873/
Number of participants that the trial has enrolled
40
Results
The median progression-free survival (PFS) was 4.3 months (95% confidence interval [CI], 2.5-5.6). The overall survival (OS) was 10.5 months (95% CI, 7.4-not reached).
Results date posted
| 2022 | Year | 07 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Lung cancer(EGFR posotive)
Participant flow
Patients who received dacomitinib for advanced EGFR-mutant NSCLC who had progressed after EGFR-TKI
Adverse events
diarrhea, paronychia, rash, and oral mucositis.
Outcome measures
PFS
OS
ORR
AE
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2021 | Year | 01 | Month | 12 | Day |
Last modified on
| 2022 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049065
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
