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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033969
Receipt No. R000038704
Scientific Title Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)
Date of disclosure of the study information 2018/08/31
Last modified on 2019/09/02

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Basic information
Public title Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)
Acronym Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)
Scientific Title Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)
Scientific Title:Acronym Observational study on the change of clonal heterogeneity by afatinib or gefitinib treatment using next generation sequencing analysis and the effect of osimertinib as a secondary treatment (CHASE study)
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To compare the change in clonal heterogeneity between afatinib and gefitinib therapy, and to investigate the correlation of the change in clonal heterogeneity with the efficacy of osimertinib.
Basic objectives2 Others
Basic objectives -Others Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change in clonal heterogeneity upon afatinib or gefinitib treatment.
Key secondary outcomes The correlation of the clonal heterogeneity with the efficacy of osimertinib.

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
70 years-old >
Gender Male and Female
Key inclusion criteria 1)Scheduled for osimertinib therapy (80mg/day, daily)
2)To collect an additional 17mL blood before osimertinib therapy is acceptable
3)FFPE tissue sample before afatinib or gefitinib therapy is available
4)Confirmed T790M acquisition at disease progression at 1st line afatinib or gefitinib therapy
5)FFPE tissue sample at the time of disease progression to afatinib or gefitinib therapy is available
6)ECOG performance status: 0 to 2
7)Life expectancy longer than 3 months
8)Adequate organ functions
9)Written informed consent
10)Age >=20 years and <70 years
Key exclusion criteria 1)Administrated other EGFR-TKI before afatinib or gefitinib treatment as 1st line therapy
2)Administrated afatinib or gefitinib as 1st line therapy and recieved other anti-tumor medicine after disease progression before prior to osimertinib therapy
3)Interstitial lung disease or pulmonary fibrosis
4)Active double cancers
5)Uncontrolled abdominal or pericardial effusion or ascites
6)With the following severe comorbidities
-Uncontrolled angina, cardiac infarct within three month, or heart failure
-Uncontrolled diabetes or hypertension
-Severe infection or comorbidities
-Significant or recent gastrointestinal disorders whose main symptom is diarrhea
-Other complications (e.g. ileus) judged to pose serious obstacles to osimeltinib therapy
7)Women who are pregnant, planning to become pregnant, or breast-feeding. Patients who are unwilling to use contraceptives
8)Patients whose physician assessed inappropriate to the study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Miyako
Middle name
Last name Satouchi
Organization Hyogo Cancer Center
Division name Department of Thoracic Oncology
Zip code 6738558
Address 13-70, Kitaoji-cho, Akashi, Hyogo
TEL 078-929-1151
Email satouchi@hp.pref.hyogo.jp

Public contact
Name of contact person
1st name Yoshihiro
Middle name
Last name Hattori
Organization Hyogo Cancer Center
Division name Department of Thoracic Oncology
Zip code 6738558
Address 13-70, Kitaoji-cho, Akashi, Hyogo
TEL 078-929-1151
Homepage URL
Email hattori@hp.pref.hyogo.jp

Sponsor
Institute Hyogo Cancer Center
Institute
Department

Funding Source
Organization Nippon Boehringer Ingelheim Co ., Ltd.
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 The ethical review boards in Hyogo Cancer Center
Address 13-70, Kitaoji-cho, Akashi, Hyogo
Tel 078-929-1151(ext.440)
Email hcc-irb@hyogo-cc.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
2018 Year 08 Month 31 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 28 Day
Date of IRB
2018 Year 03 Month 12 Day
Anticipated trial start date
2018 Year 09 Month 10 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To compare the change in clonal heterogeneity between afatinib and gefitinib therapy, and to investigate the correlation of the change in clonal heterogeneity with the efficacy of osimertinib.

Management information
Registered date
2018 Year 08 Month 31 Day
Last modified on
2019 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038704

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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