UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010526 |
|---|---|
| Receipt number | R000012308 |
| Scientific Title | Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer without epidermal growth factor receptor mutations: A phase 2 trial. |
| Date of disclosure of the study information | 2013/04/17 |
| Last modified on | 2016/06/10 09:31:51 |
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Basic information
Public title
Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer without epidermal growth factor receptor mutations: A phase 2 trial.
Acronym
Efficacy and safety of erlotinib in elderly patients with EGFR wild-type NSCLC.
Scientific Title
Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer without epidermal growth factor receptor mutations: A phase 2 trial.
Scientific Title:Acronym
Efficacy and safety of erlotinib in elderly patients with EGFR wild-type NSCLC.
Region
| Japan |
Condition
Condition
non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess the efficacy and safety of erlotinib in elderly patients aged 75 years or older with EGFR wild-type non-small-cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Reaponse rate, overall survival, safety, QOL score
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 |
Interventions/Control_1
Elderly patients with EGFR wild-type non-small-cell lung cancer receive elrotinib.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All participants must meet the following criteria
1: Histologically or pathologically proven NSCLC; stage 3b, 4, or reccurence.
2: EGFR wild type.
3: Age 75 years or older.
4: Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
4: Previously treated within one regimen chemotherapy.
6: Never received EGFR-TKI.
7: a. Hemoglobin: more than 9.0 g/dL.
b. Neutrophil count: more than 3,000/uL.
c. Platelet count: more than 100,000/uL.
d. Aspartate transaminase (AST), alanine transaminase(ALT): less than 2.5 times the upper limit of normal of the institutional reference range.
e. Total bilirubin: less than 1.5 times the upper limit of normal of the institutional reference range.
8: Life expectancy of more than 3 months
9: Written informed consent
Key exclusion criteria
Exclusion criteria are as follows
1: History of severe allergic reactions to drugs.
2: Pregnancy or lactation.
3: Willing to get pregnant.
4: Interstitial lung disease.
5: Severe infection.
6; Severe and unstable medical comorbidities.
7: Difficulty in ingestion.
8: Uncontrolled brain metastases.
9: EGFR T790M mutation.
10: Judgment to attending physician.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
TEL
053-435-2111
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Inoue |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan
TEL
053-435-2111
Homepage URL
y.inoue@hama-med.ac.jp
Sponsor or person
Institute
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 04 | Month | 17 | 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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
| 2013 | Year | 04 | Month | 17 | Day |
Last modified on
| 2016 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012308
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| Registered date | File name |
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