UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050553 |
|---|---|
| Receipt number | R000057570 |
| Scientific Title | Improved survival with osimertinib in patients with advanced EGFR-mutated non-small cell lung cancer aged 75 years or older: a subset of elderly patients in TREAD 01 |
| Date of disclosure of the study information | 2023/03/09 |
| Last modified on | 2024/12/08 11:55:02 |
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Basic information
Public title
Improved survival with osimertinib in patients with advanced EGFR-mutated non-small cell lung cancer aged 75 years or older: a subset of elderly patients in TREAD 01
Acronym
Improved survival with osimertinib in patients with advanced EGFR-mutated non-small cell lung cancer aged 75 years or older: a subset of elderly patients in TREAD 01
Scientific Title
Improved survival with osimertinib in patients with advanced EGFR-mutated non-small cell lung cancer aged 75 years or older: a subset of elderly patients in TREAD 01
Scientific Title:Acronym
Improved survival with osimertinib in patients with advanced EGFR-mutated non-small cell lung cancer aged 75 years or older: a subset of elderly patients in TREAD 01
Region
| Japan |
Condition
Condition
NSCLC
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In light of the aforementioned circumstances, the objective of this study is to examine overall survival (OS) using real-world data and retrospectively assess, without any potential harm to the patient, the efficacy of Osimertinib as a first-line treatment in elderly, untreated patients with advanced or recurrent non-small cell lung cancer who have EGFR mutations (del 19 or L858R) in clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OS
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients were consecutively enrolled from the TREAD-01 database. To be eligible for enrollment, patients had to be at least 20 years of age at the start of treatment, and have cytologically or pathologically confirmed non-small cell lung cancer with sensitizing EGFR mutations (Del19 or L858R), including those with compound EGFR mutations. Patients were categorized as having untreated stage III disease for which curative therapy was not feasible, stage IV disease (according to the 8th edition of the American Joint Committee on Cancer staging criteria for lung cancer), or recurrent disease after curative treatment. All patients were receiving first-line treatment with gefitinib, erlotinib, afatinib, dacomitinib, or osimertinib between April 2010 and 2022 at the 47 hospitals participating in the TREAD project.
Key exclusion criteria
Exclusion criteria for this study include: de novo EGFR T790M mutation, opt-outs who refused to give informed consent, insufficient data extraction such as missing details of previous cancer treatment at other hospitals or individual patient data, simultaneous or metachronous double cancers other than in situ/intramucosal cancer cured by local treatment or endoscopic lesions diagnosed as in situ cancer, or disease-free for 5 years or less.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Hibino |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Shonan Fujisawa Tokushukai Hospital
Zip code
251-0041
Address
1-5-1, Kandaitsujido, Fujisawa
TEL
0466351177
m-hibino@ctmc.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Hibino |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Resoiratory medicne
Zip code
251-0041
Address
1-5-1, Tsujidoknadai, Fujisawa
TEL
0466351177
Homepage URL
m-hibino@ctmc.jp
Sponsor or person
Institute
Shonan Fujisawa Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushukai Group Institutional Review Board
Address
Kudamminami, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-4801
homepage@tokushukai.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 | 03 | Month | 09 | Day |
Related information
URL releasing protocol
NOTHING
Publication of results
Unpublished
Result
URL related to results and publications
NOTHING
Number of participants that the trial has enrolled
0
Results
The analysis of this study was discontinued because the objectives of the study were met by other studies.
Results date posted
| 2024 | Year | 12 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NOTHING
Participant flow
NOTHING
Adverse events
NOTHING
Outcome measures
NOTHING
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2023 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is a retrospective study, and the antipipated trial start date and date analysis concluded are not consistent with reality.
Management information
Registered date
| 2023 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057570
