UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007817 |
|---|---|
| Receipt number | 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 18:30:33 |
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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
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
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009100
