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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011986
Receipt No. R000014007
Scientific Title A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer
Date of disclosure of the study information 2013/10/08
Last modified on 2013/10/08

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Basic information
Public title A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer
Acronym A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer
Scientific Title A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer
Scientific Title:Acronym A phase 2 Study of the efficay and safty of erlotinib therapy for 3/4 stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer
Region
Japan

Condition
Condition non-squamous non-small cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate efficacy and safety of erlotinib therapy for 3/4
Stage EGFR gene mutation positive EGFR-TKI untreated non-small cell lung cancer
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, Surgery rate, Pathological Complete Response Rate, Complete resection rate, Safety, Biomarker

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 150mg/day
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)stage III/IV non-squamous non-small cell lung cancer
2) EGFR gene mutation positive
3) Prior treatment of chemoradiotherapy or chemotherapy for non-small cell lung cancer patients for up to 1 regimen in the EGFR-TKI untreated
4)20 years or older
5)PS:0-2 (ECOG)
6)at least one measurable leision (RECIST)
7)patients who has the following periods
*the last prior chemotherapy:3weeks
*whole-brain irradiation(WBRT):2weeks
*stereotactic irradiation(SRI):1day
*irradiation of bone metastases:1day
*palliative radiotherapy:2weeks
*operation(surgery without lobectomy):4weeks
*operation(endoscopic surgery without lobectomy):2weeks
*biopsy with incision, port custody, and treatment to injury:1week
*pleurodesis:2weeks
*chest drainage:1weeks
8)adequate bone marrow,liver,and renal functions
*Neutrophil counts >= 1,500/mm3
*Platelets >= 100,000/mm3
*Hemoglobin concentration >= 9.0g/dL
*AST and ALT, x 2.5 of upper limit of
normal (ULN) or less
*Total bilirubin <= 1.5mg/dL
*Serum creatinin, x 1.5mg/dL of ULN or less
*SpO2(Room air) >=90%
* PT-INR < 1.5
*Protein urea <= 1+
9)a life expectancy of 3 months or more
10)written informed consent
Key exclusion criteria 1)Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.).
2)known EGFR-TKI resistance gene mutation(T790M) positive
3)history of erlotinib or gefitinib treatment
4)inable of oral drug administration
5)history of myocardial infarction and cerebral infarction within one year
6)planned surgery within study term
7)history of drug allergy
8)massive,pleural effusion or ascites
9)uncontrolled infection or serious medical complications
10)active concomitant malignancy
11)mental disorder
12)pregnant or or lactating women or those who declined contraception
13)those judged not suitable by the attending physician
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinari Ema
Organization Itabashi central medical center
Division name Department of Thoracic Surgery
Zip code
Address 2-12-7 Azusawa, Itabashi, Tokyo 174-0051
TEL 03-3967-0572
Email toshinariema09@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshinari Ema
Organization Itabashi central medical center
Division name Department of Thoracic Surgery
Zip code
Address 2-12-7 Azusawa, Itabashi, Tokyo 174-0051
TEL 03-3967-0572
Homepage URL
Email toshinariema09@yahoo.co.jp

Sponsor
Institute Itabashi central medical center
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
2013 Year 10 Month 08 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 Preinitiation
Date of protocol fixation
2013 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 31 Day
Last follow-up date
2016 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 08 Day
Last modified on
2013 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014007

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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