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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000003271
Receipt No. R000003947
Scientific Title Multicenter PhaseII trial of erlotinib for elderly patients with advanced or recurrent non-small cell lung cancer.
Date of disclosure of the study information 2010/03/01
Last modified on 2015/05/19

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Basic information
Public title Multicenter PhaseII trial of erlotinib for elderly patients with advanced or recurrent non-small cell lung cancer.
Acronym A Phase II Study of erlotinib for elderly patients with refractory or recurrent non-small cell lung cancer non-small cell lung cancer.
Scientific Title Multicenter PhaseII trial of erlotinib for elderly patients with advanced or recurrent non-small cell lung cancer.
Scientific Title:Acronym A Phase II Study of erlotinib for elderly patients with refractory or recurrent non-small cell lung cancer non-small cell lung cancer.
Region
Japan

Condition
Condition elderly patients with refractory or recurrent non-small cell lung cancer non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate 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 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Disease control rate,Safety,progression free survival,overall survival


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 Erlotinib 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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically proven stage IIIb or IV non-small cell
Lung cancer.
2) Patients who have previously treated one or two chemotherapy.
3) No previous treatment with EGFR-TKI
4) Possible cases with oral administration.
5) Patient who has at least one or more measurable lesion by RECIST.
6) performance status(ECOG)0-2
7) Patients who can be hospitalized for two weeks after beginning of the treatment or under management to apply to it.
8) Patients aged 75 years or older.
9) Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment:
* Leukocyte counts, 3,000/mm3 or over -12,000/mm3 or less.
* Neutrophil counts, 1,500/mm3 or over -5000/mm3 or less.
* Platelets, 100,000/mm3 or over.
* Hemoglobin, 9.0g/dL or over
* AST and ALT, x 2 of upper limit of normal (ULN) or less.
* Serum bilirubin, 1.5mg/dl or less.
* Serum creatinin, x 1.5 of ULN or less.
* SpO2 90% or above(room air).
10) Patients who are considered to survive for more than 3 months.
11) Interval
(1) Chemotherapy: more than 4weeks after the last chemotherapy
(2) Radiation: more than 12weeks after the thoracic irradiation or more than 2weeks after the last irradiation to the other organs
(3) Operation: more than 4weeks after the last operation(including pleurodesis)
12) 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.
[ex) gefitinib, lapatinib, trsutuzumab, cetuximab]
5) Impossible cases with oral administration.
6) Patients with active opthalmological disease.
7) Patients with active concomitant malignancy.
8) Patients with symptomatic brain metastasis.
9) Patients with double cancer.
10) Patients with uncontrollabe diabetes mellitus.
11) Patients with uncontrollable complications.
12) Inappropriate patients for this study judged by the physicians.
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Nakanishi
Organization Kyushu University, Graduate School of Medical Sciences
Division name Research Institute for Diseases of the Chest
Zip code
Address 3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL 092-642-5378
Email yoichi@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Takayama
Organization Kyushu University, Graduate School of Medical Sciences
Division name Research Institute for Diseases of the Chest
Zip code
Address 3-1-1 Maidashi, higashi-ku, Fukuoka, Japan , 812-8582
TEL 092-642-5378
Homepage URL
Email koichi-t@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 九州大学病院(福岡県)
浜の町病院(福岡県)
福岡大学(福岡県)
国立病院機構 福岡東医療センター(福岡県)
済生会福岡総合病院(福岡県)
国立病院機構 九州医療センター(福岡県)
公立学校共済組合 九州中央病院(福岡県)
国立病院機構 福岡病院 (福岡県)
飯塚病院(福岡県)
産業医科大学病院(福岡県)
国立病院機構 大牟田病院(福岡県)
九州厚生年金病院(福岡県)
福岡大学 筑紫病院(福岡県)
久留米大学(福岡県)
北九州市立医療センター(福岡県)
大分大学(大分県)
新別府病院(大分県)
大分県立病院(大分県)
アルメイダ病院(大分県)
佐賀大学(佐賀県)
佐賀県立病院好生館(佐賀県)
長崎大学(長崎県)
健康保険諫早総合病院(長崎県)
春回会 井上病院(長崎県)
熊本地域医療センター(熊本県)
国立病院機構 熊本再春荘病院(熊本県)
熊本中央病院(熊本県)
熊本赤十字病院(熊本県)
国立病院機構 熊本医療センター(熊本県)
宮崎大学(宮崎県)
宮崎県立宮崎病院(宮崎県)
鹿児島大学(鹿児島県)
国立病院機構 南九州病院(鹿児島県)
川内医師会立市民病院(鹿児島県)
鹿児島厚生連病院(鹿児島県)
今給黎総合病院(鹿児島県)
浦添総合病院(沖縄県)
琉球大学(沖縄県)
沖縄県立南部医療センター・こども医療センター(沖縄県)
国立病院機構 沖縄病院(沖縄県)
松山赤十字病院(愛媛県)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 01 Day

Related information
URL releasing protocol http://www.logik.jp/
Publication of results Published

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 Main results already published
Date of protocol fixation
2009 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2015 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 01 Day
Last modified on
2015 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003947

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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