UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2011 Year 10 Month 08 Day
Date of IRB	2012 Year 03 Month 29 Day
Anticipated trial start date	2012 Year 04 Month 27 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	2021 Year 02 Month 15 Day

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