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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007817
Receipt No. R000009100
Scientific Title Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.
Date of disclosure of the study information 2012/05/14
Last modified on 2018/03/01

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Basic information
Public title Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.
Acronym Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.
Scientific Title Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.
Scientific Title:Acronym Exploratory study of detection of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of detection method of mutated EGFR from plasma of patients with EGFR mutant non-small cell lung cancer resistant to EGFR-TKI.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection rate of mutated EGFR from plasma
Key secondary outcomes T790M mutation rate, Serum HGF, Progression-free survival (PFS), Toxicities

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Detection of mutated EGFR from plasma; gefitinib plus either S-1 or pemetrexed therapy
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 proven non-small cell lung cancer (NSCLC)
2) Stage IIIB or IV disease
3) NSCLC with EGFR mutation (ex19 deletions or L858R)
4) NSCLC resistant to EGFR-TKI (intrinsic or acquired resistance)
5 ) Previously administered EGFR-TKI over 28 days
6) Undergoing EGFR-TKI monotherapy
7) Aged 20 years or older
8) ECOG performance status 0-2
9) One or more measurable lesions
10) No experience of either S-1 or pemetrexed
11) Experience of platinum use or considered to be ineligible for platinum-based therapy
12) Interval of at least 2 weeks from last surgical procedure or radiation therapy
13) Adequate bone marrow, renal, hepatic and cardiopulmonary function
14) Able to take oral medication
15) Life expectancy of at least 12 weeks
16) Written informed consent
Key exclusion criteria 1) Interstital pneumonitis
2) Uncontrolled intercurrent illness
3) Active infection
4) Need for treatment within 6 months for double cancer
5) Symptomatic CNS metastases
6) Massive pleural effusion or ascites
7) History of irradiation to more than half of pelvic bone
8) Allergy to treatment drugs
9) Pregnant or breast-feeding
10) Unwilling to use adequate contraception
11) Other conditions inadequate for this research
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Hosomi
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Department of Thoracic Oncology and Respiratory Medicine
Zip code
Address 3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Takagi
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Department of Thoracic Oncology and Respiratory Medicine
Zip code
Address 3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization Tokyo metropolitan government
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 05 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27601920
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 Terminated
Date of protocol fixation
2012 Year 04 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 23 Day
Last modified on
2018 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009100

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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