UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014091 |
|---|---|
| Receipt number | R000016286 |
| Scientific Title | Study of association between effect of afatinib for EGFR-mutated non-small cell lung cancer and circulating free DNA detected with high sensitive analyses for EGFR mutation. |
| Date of disclosure of the study information | 2014/05/28 |
| Last modified on | 2021/08/06 19:54:03 |
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Basic information
Public title
Study of association between effect of afatinib for EGFR-mutated non-small cell lung cancer and circulating free DNA detected with high sensitive analyses for EGFR mutation.
Acronym
Analysis of ctDNA and afatinib
Scientific Title
Study of association between effect of afatinib for EGFR-mutated non-small cell lung cancer and circulating free DNA detected with high sensitive analyses for EGFR mutation.
Scientific Title:Acronym
Analysis of ctDNA and afatinib
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
By a high sensitive analysis, we try to detect EGFR activating mutations and resistant mutations from plasma of NSCLC patients receiving afatinib after treatment with first-generation EGFR-TKI. We also evaluate relationship between effect of afatinib and EGFR mutation status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
detection rate of circulating free DNA from plasma after treatment for 2 months
Key secondary outcomes
association between amount of circulating free DNA and effect of 2nd generation EGFR-TKI (PFS, OS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Gene |
Interventions/Control_1
From May 2014 to March 2016
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.Histologically or cytologically confirmed non-squamous, non-small cell lung cancer
2.Stage or recurrent disease
3.EGFR mutation (exon 19 deletion,L858R) detected by PNA-LNA PCR clamp method
4.Discontinuation of 1st generation EGFR-TKI due to PD or toxicity
5.Planned treatment with afatinib
6.ECOG performance status (PS) 0 to 2
7.Adequate organ functions
8.Written informed consent
Key exclusion criteria
1.Interstitial pneumonitis or pulmonary fibrosis apparent on chest X-ray
2.Concomitant malignancies
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Maemondo |
Organization
Miyagi Cancer Center
Division name
Respiratory Medicine
Zip code
Address
17-1 Nodayama Shiote Medeshima Natorishi Miyagi 981-1293
TEL
022-384-3151
maemond-ma693@miyagi-pho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Maemondo |
Organization
Miyagi Cancer Center
Division name
Respiratory Medicine
Zip code
Address
17-1 Nodayama Shiote Medeshima Natorishi Miyagi 981-1293
TEL
022-384-3151
Homepage URL
maemond-ma693@miyagi-pho.jp
Sponsor or person
Institute
Makoto Maemondo
Institute
Department
Personal name
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
Address
Tel
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
| 2014 | Year | 05 | Month | 28 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 27 | Day |
Last modified on
| 2021 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016286
