UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037452 |
|---|---|
| Receipt number | R000042689 |
| Scientific Title | A observational study to evaluate afatinib followed by osimertinib |
| Date of disclosure of the study information | 2019/07/22 |
| Last modified on | 2019/12/24 17:27:15 |
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Basic information
Public title
Sequential therapy from afatinib to osimertinib for EGFR-mutant non-small cell lung cancer: a multicenter prospective observational study (Gio-Tag Japan)
Acronym
Gio-Tag Japan
Scientific Title
A observational study to evaluate afatinib followed by osimertinib
Scientific Title:Acronym
Afa-Osi for EGFR-mutant NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate sequential therapy of first-line afatinib followed by osimertinib in a prospective Japanese real world data
To investigate T790M incidence after afatinib resistance using highly sensitive ddPCR in translational research
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Time on treatment of afatinib followed by osimertinib
Key secondary outcomes
OS, RR/PFS of afatinib, RR/PFS of osimertinib, efficacy of afatinib by dosages, incidence of rebiopsy, positive-rate of T790M by cobas, positive-rate of T790M by ddPCR, TOT of afatinib followed by chemotherapy other than osimertinib, and TD-TKI
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
1. Written informed consent
2. Histologically or cytologically conformed NSCLC
3. EGFR-mutant (Del-19 or L858R)
4. Advanced disease without indication of surgery and CRT
5. Afatinib will be administered as the first-line therapy
6. Aged older than 20
7. PS (ECOG) 0/1
Key exclusion criteria
1. Active double cancer
2. No interstitial lung disease
3. No uncontrolled comorbidities
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Katakami |
Organization
Takarazuka City Hospital
Division name
Department of Medical Oncology
Zip code
665-0827
Address
5-1, 4 chome, Kohama, Takarazuka
TEL
0797-87-1161
klog@jcom.zaq.ne.jp
Public contact
Name of contact person
| 1st name | Akito |
| Middle name | |
| Last name | Hata |
Organization
Kobe Minimally Invasive Cancer Center
Division name
Department of Thoracic Oncology
Zip code
650-0046
Address
8-5-1, Minatojima-nakamachi, Chuo-ku, Kobe
TEL
078-304-4100
Homepage URL
akitohata@hotmail.com
Sponsor or person
Institute
HANSHIN Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Boehringer Ingelheim
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takarazuka City Hospital
Address
5-1, 4 chome, Kohama, Takarazuka
Tel
0797-87-1161
klog@jcom.zaq.ne.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
全国から約60施設を予定
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 22 | 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
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2019 | Year | 07 | Month | 22 | Day |
Last modified on
| 2019 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042689
| 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 |
