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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042975
Receipt No. 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 2021/01/12

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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
Email 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
Email xyghx335@gmail.com

Sponsor
Institute TOPGAN group
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 40
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 No longer recruiting
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
2021 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049065

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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