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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006518
Receipt No. R000007731
Scientific Title Phase II study of erlotinib in advanced or recurrent EGFR mutation positive Non-small cell lung cancer patients who were previously treated with intrapleural therapy for malignant pleural effusion.
Date of disclosure of the study information 2011/10/12
Last modified on 2011/10/11

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Basic information
Public title Phase II study of erlotinib in advanced or recurrent EGFR mutation positive Non-small cell lung cancer patients who were previously treated with intrapleural therapy for malignant pleural effusion.
Acronym Phase II study of erlotinib in advanced or recurrent EGFR mutation positive NSCLC patients who were previously treated with intrapleural therapy for malignant pleural effusion.
Scientific Title Phase II study of erlotinib in advanced or recurrent EGFR mutation positive Non-small cell lung cancer patients who were previously treated with intrapleural therapy for malignant pleural effusion.
Scientific Title:Acronym Phase II study of erlotinib in advanced or recurrent EGFR mutation positive NSCLC patients who were previously treated with intrapleural therapy for malignant pleural effusion.
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 efficacy and safety of erlotinib in advanced or recurrent EGFR mutation positive non-small cell lung cancer patients who were previously treated with intrapleural therapy for malignant pleural effusion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Disease control rate, Progression free survival, Overall survival, Adverse events, 4-weeks pleural effusion progression free survival rate, Pleural effusion progression free suvival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1,Cytologically or histologically proven non-small cell lung cancer
2)Cytologically or histologically proven malignant pleural effusion associated with non-small cell lung cancer
3,Clinical stage IV or post-operative recurrence
4,Prior tube thoracostomy followed by intrapleural therapy for malignant pleural effusion
5,EGFR mutation positive
6,No prior EGFR tyrosine kinase inhibitor treatment
7,ECOG Performance status 0-3 after tube thoracostomy
8,Adequate organ functions
9,Mesurable lesions (RECIST)
10,Adequate interval after prior treatments; 2 weeks from OK-432, Talc, 6 weeks from Mitomycin
11,Written informed consent
Key exclusion criteria 1,Massive pericardial effusion or ascites
2,Severe drug allergy
3,Active infection
4,Continuous watery diarrhea
5,Intestinal paralysis or ileus
6,Interstitial pneumonia or lung fibrosis evident on CT
7,Symptomatic ophthalmologic disease
8,Current or previous (within the last 1 year) history of GI perforation
9,Serious non—healing ulcer
10,Symptomatic or steroid-requiring brain metastases
11,Active concomitant malignancy
12,Previous (within the last 5 years) concomitant malignancy
13,Uncontrolled diabetes
14,Severe cardiac disease
15,Severe psychological disease
16,Pregnant or lactating women or those who declined contraception
17,Those judged to be not suitable by the attending physician
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Masuda
Organization Kitasato university hospital
Division name Department of respiratory medicine
Zip code
Address 1-15-1, Kitasato, Sagamihara, Kanagawa, 252-0375
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Michiko Yamamoto
Organization Kitasato university hospital
Division name Department of respiratory medicine
Zip code
Address 1-15-1, Kitasato, Sagamihara, Kanagawa, 252-0375
TEL
Homepage URL
Email

Sponsor
Institute Kitasato university hospital
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

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 12 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 Open public recruiting
Date of protocol fixation
2011 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 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
2011 Year 10 Month 11 Day
Last modified on
2011 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007731

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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