UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016765 |
|---|---|
| Receipt number | 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 16:32:02 |
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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
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
igishi@med.tottori-u.ac.jp
Sponsor or person
Institute
Division of Medical Oncology and Molecular Respirology, Faculty of Medicine, Tottori University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019347
