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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001873
Receipt No. 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

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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
Email 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
Email naoki@z5.keio.jp

Sponsor
Institute Keio University School of Medicine Division of Pulmonary Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002257

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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