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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012725
Receipt No. R000014866
Scientific Title Phase II study of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations
Date of disclosure of the study information 2014/01/02
Last modified on 2013/12/29

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Basic information
Public title Phase II study of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations
Acronym Phase II study of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations
Scientific Title Phase II study of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations
Scientific Title:Acronym Phase II study of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Surgery in general Chest surgery Radiology
Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of neoadjuvant erlotinib in patients with stage III-N2 non-small cell lung cancer with EGFR mutations
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Radical resection rate
Key secondary outcomes

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 Maneuver
Interventions/Control_1 Patients will receive daily erlotinib at 150mg/day for six weeks. The patients with responsive disease considered to be technically resectable will undergo surgical resection.
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 proven non-small cell lung cancer
2) cStageIII-N2
3) Activating EGFR mutations
4) Without previously treatment for lung cancer
5) Has measurable by RECIST (ver. 1.1) criteria
6) ECOG performance status 0-1
7) Age >= 20 years
8) Adequate organ function
Absolute neutrophil count (ANC) >= 1,500/mm3
Platelets >= 100000/mm3
Hemoglobin >= 9.0g/dL
AST and ALT <= 2.5 x ULN
Total bilirubin <= 1.5 x ULN
Serum creatinine <= 1.5 x ULN
SpO2 >= 90%
9) Life expectancy more than 3 months
10) Signed written informed consent
Key exclusion criteria 1) Active lung disease such as interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or medicine-induced pneumonitis
2) Prior exposure to agents directed at the HER axis (e.g. erlotinib, gefetinib, cetuximab, trastuzumab)
3) Gastrointestinal abnormalities, including active peptic ulcer or inflammatory bowel disease
4) Active ophthalmologic diseases (e.g. Sjogrens)
5) Neurological symptoms of spinal cord compression
6) Uncontrolled infections
7) History of severe heart disease
8) Serious medical complications
9) Multiple primary cancer
10) Serious psychiatric illness or psychological symptom
11) Women who are pregnant, lactating or with childbearing potential
12) Ineligible based on decision of an investigator.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Kikuchi
Organization Tsukuba University Hospital
Division name Department of Thoracic Surgery
Zip code
Address 1-1-1 Tennodai,Tsukuba 305-8575 Japan
TEL 029-853-5600(90169)
Email S.kikuchi@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Kikuchi
Organization Tsukuba University Hospital
Division name Department of Thoracic Surgery
Zip code
Address 1-1-1 Tennodai,Tsukuba 305-8575 Japan
TEL 029-853-5600(90169)
Homepage URL
Email S.kikuchi@md.tsukuba.ac.jp

Sponsor
Institute Department of Thoracic Surgery, Tsukuba 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
2014 Year 01 Month 02 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
2013 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 02 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 12 Month 29 Day
Last modified on
2013 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014866

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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