UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004046 |
|---|---|
| Receipt number | R000004878 |
| Scientific Title | A phase II study of erlotinib for gefitinib-resistant non-small cell lung cancer without T790M mutation analyzed in the circulating tumor cell |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2013/04/04 14:27:43 |
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Basic information
Public title
A phase II study of erlotinib for gefitinib-resistant non-small cell lung cancer without T790M mutation analyzed in the circulating tumor cell
Acronym
Erlotinib for gefitinib-resistant NSCLC without T790M in CTC
Scientific Title
A phase II study of erlotinib for gefitinib-resistant non-small cell lung cancer without T790M mutation analyzed in the circulating tumor cell
Scientific Title:Acronym
Erlotinib for gefitinib-resistant NSCLC without T790M in CTC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of erlotinib for gefitinib-resistant non-small cell lung cancer without T790M in circulating tumor cell
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective response rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
erlotinib
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.Advanced non-small cell lung cancer harboring EGFR sensitive mutation
2. Pretreated with gefitinib and re-growth was detected
3. Without T790M in the analysis of circulation tumor cell
4. Adequate organ functions, PS0-2
5. Written informed concent
Key exclusion criteria
1. Clinical symptomatic brain metastasis
2. With severe co-morbidities
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Inoue |
Organization
Tohoku University Hospital
Division name
Department of respiratory medicine
Zip code
Address
1-1, Seiryo-machi, Aobaku, Sendai
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tohoku University Hospital
Division name
Department of respiratory medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
North-East Japan Study Group
Institute
Department
Personal name
Funding Source
Organization
Grant from MEXT in Japan
Organization
Division
Category of Funding Organization
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
| 2010 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
| 2010 | Year | 08 | Month | 16 | Day |
Last modified on
| 2013 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004878
| 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 |
