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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016765
Receipt No. R000019347
Scientific Title Phase II Study of Vinorelbine + TS-1 in Patients with EGFR-mutated Advanced Non-small Cell Lung Cancer
Date of disclosure of the study information 2015/03/11
Last modified on 2015/03/10

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Basic information
Public title Phase II Study of Vinorelbine + TS-1 in Patients with EGFR-mutated Advanced Non-small Cell Lung Cancer
Acronym Phase II Study of Vinorelbine + TS-1 in Patients with EGFR-mutated Advanced Non-small Cell Lung Cancer
Scientific Title Phase II Study of Vinorelbine + TS-1 in Patients with EGFR-mutated Advanced Non-small Cell Lung Cancer
Scientific Title:Acronym Phase II Study of Vinorelbine + TS-1 in Patients with EGFR-mutated Advanced Non-small Cell Lung Cancer
Region
Japan

Condition
Condition EGFR-mutated non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of the combination of vinorelbine and TS-1 in patients with EGFR-mutated non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Disease control rate, Overall survival, Response rate, Safety

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 To evaluate safety and efficacy of the combination of vinorelbine and TS-1 in patients with EGFR-mutated non-small cell lung cancer
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 Histological or cytological diagnosis of non-small cell lung cancer
2 Unresectable
3 Have measurable lesions
4 No prior chemotherapy excluding gefitinib or elrotinib
5 EGFR mutation (including T790M)-positive
6 ECOG Performance Status (PS) 0 to 1
7 Life expectancy of more than three months
8 patients aged 20 years or older
9 Have adequate function of major organs (bone marrow, liver, kidneys) defined as follows
(1)White blood cell >= 4,000/mm3
(2)Neutrophils >= 2,000/mm3
(3)Hemoglobin >=10.0g/dl
(4)Platelets>=100,000/mm3
(5)Total bilirubin<=1.5mg/dl
(6)AST(GOT) <=2xULN
(7)ALT(GPT) <=2xULN
(8)creatinine clearance >= 60ml/min
(9)PaO2>= 60mmHg
10 Oral intake
11 Normal electrocardiogram
12 Provided written consent in person for participation in this study
Key exclusion criteria 1 Patient with need of procedure for pleural effusion
2 Patient with need of drainage procedure for cardiac effusion
3 Patient with symptomatic brain metastasis
4 Patient with severe complications5
5 Patients with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X-ray
6 Female Patient in or having a chance or planning of pregnancy or breast feeding
7 Male patient in planning to impregnate
8 Patient with active multiple cancers
9 Patients with history of drug hypersensitivity
10 Patients with histoly of hypersensitivity against vinorelbine or other vinca alkaloids
11 Patients with histoly of hypersensitivity against TS-1 or pyrimidine fluoride
12 Being treated with other pyrimidine fluoride
13 Being treated with flucytosine
14 Any patients judged by the investigator to be unfit to participate in the study
Target sample size 37

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Shimizu
Organization Faculty of Medicine, Tottori University
Division name Division of Medical Oncology and Molecular Respirology
Zip code
Address 86 Nishi-machi, Yonago, Tottori Japan
TEL 0859-38-6537
Email eiji@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Igishi
Organization Faculty of Medicine, Tottori University
Division name Division of Medical Oncology and Molecular Respirology
Zip code
Address 86 Nishi-machi, Yonago, Tottori Japan
TEL 0859-38-6537
Homepage URL
Email igishi@med.tottori-u.ac.jp

Sponsor
Institute Division of Medical Oncology and Molecular Respirology, Faculty of Medicine, Tottori University
Institute
Department

Funding Source
Organization Division of Medical Oncology and Molecular Respirology, Faculty of Medicine, Tottori University
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 鳥取大学医学部附属病院(鳥取県)、鳥取県立中央病院(鳥取県)、松江赤十字病院(島根県)、米子医療センター(鳥取県)、松江医療センター(島根県)、松江市立病院(島根県)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 11 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 Enrolling by invitation
Date of protocol fixation
2011 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 10 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
2015 Year 03 Month 10 Day
Last modified on
2015 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019347

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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