UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007020
Receipt No. R000008231
Scientific Title Phase II study of Erlotinib in previously treated advanced non-small cell lung cancer patients with carcinomatous meningitis
Date of disclosure of the study information 2012/01/05
Last modified on 2016/12/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II study of Erlotinib in previously treated advanced non-small cell lung cancer patients with carcinomatous meningitis
Acronym Phase II study of Erlotinib in previously treated advanced non-small cell lung cancer patients with carcinomatous meningitis
Scientific Title Phase II study of Erlotinib in previously treated advanced non-small cell lung cancer patients with carcinomatous meningitis
Scientific Title:Acronym Phase II study of Erlotinib in previously treated advanced non-small cell lung cancer patients with carcinomatous meningitis
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy of Erlotinib in previously treated advanced non-small cell lung cancer patients with carcinomatous meningitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Overall survival
Meningitis progression free survival
Adverse event
Examination of cerebrospinal fluid
Performance status
Quality of life

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
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)Histologically or cytologically confirmed Non-small cell lung cancer(NSCLC)
2)Previously treated (prior Gefitinib treatment is allowed)
3)Cytologically confirmed carcinomatous meningitis associated with NSCLC
4)Age>=20years
5)ECOG PS 1-3
6)Adequate organ functions
1.WBC >= 3000 /mm3
2.Plt > 75000 /mm3
3.AST and ALT <= 100 IU/ml
4.T-Bil <= 1.5 mg/dl
5.SpO2 >= 90%
7)Written informed consent


Key exclusion criteria 1)Prior elrotinib treatment with the exception of elrotinib discontinuation for four weeks or more at study enrollment.
2)Active interstitial pneumonia or pulmonary fibrosis on chest CT scan
3)Severe drug allergy
4)Prior radiotherapy to chest within 2 weeks
5)Massive pleural effusion, ascites or pericardial effusion
6)Active infection
7)Continuous watery diarrhea
8)Intestinal paralysis or ileus
9)Symptomatic ophthalmologic disease
10)Current or previous (within the last 1 year) gastrointestinal perforation
11)Severe ulcer
12)Severe cardiac disease
13)Severe psychological disease
14)Pregnant or breast-feeding females or those who declined contraception
15)Inappropriate patients for this study judged by the attending physician
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Takenoyama
Organization National Kyushu Cancer Center
Division name Department of Thoracic Oncology
Zip code
Address 3-1-1, Notame, Minami-ku, Fukuoka, Japan, 811-1395
TEL 092-541-3231
Email takenoyama.m@nk-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaname Nosaki
Organization National Kyushu Cancer Center
Division name Department of Thoracic Oncology
Zip code
Address 3-1-1, Notame, Minami-ku, Fukuoka, Japan, 811-1395
TEL 092-541-3231
Homepage URL
Email nosaki.k@nk-cc.go.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 飯塚病院(福岡県)
北九州総合病院(福岡県)
九州大学(福岡県)
九州労災病院(福岡県)
久留米大学(福岡県)
国立病院機構大牟田病院(福岡県)
国立病院機構九州がんセンター(福岡県)
国立病院機構小倉医療センター(福岡県)
国立病院機構福岡東医療センター(福岡県)
国立病院機構福岡病院(福岡県)
浜の町病院(福岡県)
福岡青洲会病院(福岡県)
大分赤十字病院(大分県)
新別府病院(大分県)
JCHO諫早総合病院(長崎県)
十善会病院(長崎県)
長崎大学(長崎県)
日本赤十字社 長崎原爆病院(長崎県)
熊本地域医療センター(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)
宮崎県立宮崎病院(宮崎県)
鹿児島厚生連病院(鹿児島県)
川内市医師会立市民病院(鹿児島県)
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)
国立病院機構岩国医療センター(山口県)

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 05 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 Main results already published
Date of protocol fixation
2011 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2016 Year 05 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
2012 Year 01 Month 05 Day
Last modified on
2016 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008231

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.