UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001873 |
|---|---|
| Receipt number | R000002257 |
| Scientific Title | PhaseII trial of erlotinib for elderly patients with advanced or recurrent non-small cell lung cancer |
| Date of disclosure of the study information | 2009/04/11 |
| Last modified on | 2015/08/01 09:29:02 |
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Basic information
Public title
PhaseII trial of erlotinib for elderly patients with advanced or recurrent non-small cell lung cancer
Acronym
Erlotinib for elderly patients with advanced or recurrent non-small cell lung cancer
Scientific Title
PhaseII trial of erlotinib for elderly patients with advanced or recurrent non-small cell lung cancer
Scientific Title:Acronym
Erlotinib for elderly patients with advanced or recurrent non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of erlotinib for elderly patients with refractory or recurrent non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Anticancer efficacy(response rate and disease control rate)
Key secondary outcomes
Progression free survival, overall survival,and safety
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
Elrotinib treatment
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histlogically or cytologically confirmed stage III/IV non-small cell lung cancer
2)Refractory cases to the prior one or two chemotherapies
3)No prior treatment with EGFR-TKI
4)Possible cases with oral administration
5)Patients with mesearable lesions as defined by RECIST
6)Performance Status(ECOG) 0-2
7)>= 70 years of age
8)Patients with adequate organ functions
9)Life expectancy more than three months
10)
(a)Chemotherapy: more than 4weeks after the last chemotherapy
(b)Radiation: more than 12weeks after the thoracic irradiation or more than 2weeks after the last irradiation to the other organs
(C)Operation: more than 4weeks after the last operation(including pleurodesis)
11)Written informed consent
Key exclusion criteria
1)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis
2)Patients with massive pleural or pericardial effusion ,or ascites
3)Patients with active severe infections
4)Cases with past history of administration of HER related agents
5)Impossible cases with oral administration
6)Patients with active opthalmological disease
7)Patients with symptomatic brain metastasis
8)Patients with active concomitant malignancy
9)Patients with uncontrollabe diabetes mellitus
10)Patients with uncontrollable complications
11)Inappropriate patients for this study judged by the physicians
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenzo Soejima |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine
Zip code
Address
35 Shinomachi-Shinjyuku
TEL
03-3353-1211
ksoejima@cpnet.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiko Naoki |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine
Zip code
Address
35 Shinomachi-Shinjyuku
TEL
03-3353-1211
Homepage URL
naoki@z5.keio.jp
Sponsor or person
Institute
Keio University School of Medicine Division of Pulmonary Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine Division of Pulmonary Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2009 | Year | 04 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 11 | Day |
Last modified on
| 2015 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002257
