UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011473
Receipt No. R000013428
Scientific Title Phase II study of erlotinib monotherapy for patients with untreated advanced non-small cell lung cancer, poor performance status and positive EGFR mutation status (OSAKA-LCSG1304)
Date of disclosure of the study information 2013/08/27
Last modified on 2015/06/30

* 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 monotherapy for patients with untreated advanced non-small cell lung cancer, poor performance status and positive EGFR mutation status (OSAKA-LCSG1304)
Acronym OSAKA-LCSG1304
Scientific Title Phase II study of erlotinib monotherapy for patients with untreated advanced non-small cell lung cancer, poor performance status and positive EGFR mutation status (OSAKA-LCSG1304)
Scientific Title:Acronym OSAKA-LCSG1304
Region
Japan

Condition
Condition 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 monotherapy for patients with untreated advanced non-small cell lung cancer, poor performance status and positive EGFR mutation status
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall Survival (OS)
Key secondary outcomes Progression Free Survival (PFS), Response Rate (RR), Frequency and grade of adverse event, QOL(EORTC QLQ-PAL15)

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) 20 years-old or older
(2) Histologically or cytologically confirmed non-small cell lung cancer
(3) Stage III/IV non-small cell lung cancer without any indications for radiotherapy or surgery, or recurrence 6 months after postoperative adjuvant chemotherapy
(4) With positive EGFR mutation status (deletion of exon 19 or L858R point mutation in exon 21), and without T790M point mutation status in exon 20
(5) ECOG performance status of 3 to 4
(6) Evaluable disease (RECIST ver1.1)
(7) No history of EGFR-TKI
(8) Adequate organ function, evaluated within 14 days before enrollment as;
ALT =or< 100IU/L
Total bilirubin =or< 2.0mg/dL
(9) Interval; 3 weeks after immunotherapy or hormone therapy, 2 weeks after pleurodesis with anti-tumor agent
(10) Written informed consent
Key exclusion criteria (1) Problematic infection that requires anti-biotic, anti-fungal agent or anti-viral agent
(2) Current or previous history of pulmonary fibrosis, interstitial pneumonitis or drug-induced pneumonia, revealed by chest CT or with clinical symptoms
(3) A history of severe hypersensitivity against erlotinib
(4) Difficulty in oral administration of erlotinib, functional / organic impairment or inflammatory bowel disease that disturbs absorption of erlotinib
(5) Another active advanced malignancy that requires any concurrent treatment with treatment for lung cancer
(6) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
(7) Psychologically ineligible
(8) Decision of ineligibility by a physician
Target sample size 23

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seigo Minami
Organization Osaka Police Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 10-31 Kitayama-cho, Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
TEL 06-6771-6051
Email

Public contact
Name of contact person
1st name
Middle name
Last name Seigo Minami
Organization Osaka Police Hospital
Division name Dept. of Respiratory Medicine
Zip code
Address 10-31 Kitayama-cho, Tennoji-ku, Osaka-city, Osaka 543-0035, Japan
TEL 06-6771-6051
Homepage URL
Email

Sponsor
Institute OSAKA-LCSG
Institute
Department

Funding Source
Organization None
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 大阪警察病院(大阪府)、大阪大学医学部付属病院(大阪府)、市立豊中病院(大阪府)、大阪府済生会千里病院(大阪府)、大阪府立急性期総合医療センター(大阪府)、大阪府立呼吸器・アレルギー医療センター(大阪府)、大阪府立成人病センター(大阪府)、国立病院機構 近畿中央胸部疾患センター(大阪府)、公立学校共済組合 近畿中央病院(兵庫県)、国立病院機構 刀根山病院(大阪府)、西宮市立中央病院(兵庫県)、日本生命済生会 日生病院(大阪府)、国立病院機構 大阪南医療センター(大阪府)、関西医科大学附属枚方病院(大阪府)、関西医科大学附属滝井病院(大阪府)、箕面市立病院(大阪府)、市立吹田市民病院(大阪府)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 27 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 Terminated
Date of protocol fixation
2013 Year 08 Month 13 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 13 Day
Last modified on
2015 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013428

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.