UMIN-CTR Clinical Trial

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

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES

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

Primary outcomes

Response rate

Key secondary outcomes

Overall survival
Meningitis progression free survival
Adverse event
Examination of cerebrospinal fluid
Performance status
Quality of life

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Lung Oncology Group in Kyushu, Japan (LOGIK)

Institute

Department

Personal name

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2012

Year

01

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

01

Month

05

Day

Last modified on

2021

Year

02

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008231