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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044101
Receipt No. R000050361
Scientific Title A multi-institutional retrospective study of osimertinib for elderly patients with previously untreated advanced non-small cell lung cancer harboring EGFR mutations (HOT2002)
Date of disclosure of the study information 2021/05/04
Last modified on 2021/05/03

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Basic information
Public title A multi-institutional retrospective study of osimertinib for elderly patients with previously untreated advanced non-small cell lung cancer harboring EGFR mutations (HOT2002)
Acronym HOT2002
Scientific Title A multi-institutional retrospective study of osimertinib for elderly patients with previously untreated advanced non-small cell lung cancer harboring EGFR mutations (HOT2002)
Scientific Title:Acronym HOT2002
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical course, efficacy and safety of osimertinib for elderly patients with previously untreated advanced non-small cell lung cancer harboring EGFR mutations
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the proportion of patients who were progression-free survival at 1 year (1-year PFS)
Key secondary outcomes safety profile, objective response rate (ORR), disease control rate (DCR), PFS, and overall survival (OS)

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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Advanced/Relapsed non-small cell lung cancer
2.Patients who received first-line osimertinib between August 2018 and December 20119
Key exclusion criteria Patients who had received other EGFR-TKIs before receiving osimertinib were excluded.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hajime
Middle name
Last name Asahina
Organization Hokkaido University Graduate school of Medicine
Division name Department Respiratory Medicine, Faculty of Medicine
Zip code 060-8638
Address North 15, West 7, Kita-ku, Sapporo, Japan
TEL 011-706-5911
Email asahinah@pop.med.hokudai.ac.jp

Public contact
Name of contact person
1st name Gaku
Middle name
Last name Yamamoto
Organization Hokkaido University Graduate school of Medicine
Division name Department Respiratory Medicine, Faculty of Medicine
Zip code 060-8638
Address Kita 14, North 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL 011-706-5911
Homepage URL
Email gaku.yamamoto0306@pop.med.hokudai.ac.jp

Sponsor
Institute Hokkaido Lung Cancer Clinical Study Group(HOT)
Institute
Department

Funding Source
Organization None
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 Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address Kita 14, North 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
Tel 011-706-7636
Email crjimu@huhp.hokudai.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 05 Month 04 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 132
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 17 Day
Date of IRB
2020 Year 08 Month 17 Day
Anticipated trial start date
2020 Year 08 Month 17 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 02 Month 28 Day
Date trial data considered complete
2021 Year 02 Month 28 Day
Date analysis concluded
2021 Year 04 Month 30 Day

Other
Other related information Retrospective observational study

Management information
Registered date
2021 Year 05 Month 03 Day
Last modified on
2021 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050361

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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