UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I and II study of S-1+vinorelbine in patients with advanced non-small cell cancer
Title of the study (Brief title)	Phase I and II study of S-1+vinorelbine in patients with advanced non-small cell cancer
Region	Japan

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

Objectives
Narrative objectives1	To determine recommended dose of S-1 and vinorelbine in phase I study, and to evaluate safety and efficacy of the combination of vinorelbine and S-a in patients with advanced non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I study: recommended dose Phase II study: 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 determine recommended dose of S-1 and vinorelbine in phase I study, and to evaluate safety and efficacy of the combination of vinorelbine and S-a in patients with advanced 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. Histlogical or cytological diagnosis of non-small cell lung cancer 2. Unresectable 3. Have measurable lesions 4. No prior chemotherapy exclusing gefitinib of erlotinib 5. ECOG Performance status (PS) 0 to 1 6. Life expectancy of more than three months 7. patients aged 20 years of older 8. Have adequate function of maijor organs(bone marrow, liver, kidneys) 9. Oral intake 10. normal electrocardiogram 11. 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 complications 5. Patient with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X-ray 6. Female patient in or having achance or planning of pregnancy or breast feeding 7. Male patient in plannning to impregnate 8. Patient with active multiple cancers 9. Patient with history of drug hypersensitivity 10. Patient with history of hypersensitivity against vinorelbine or other vinca alkaloids 11. Patient with history of hypersensitivity against TS-1 or pyrimidine fluoride 12. Being treated with other pyrimidine fluoride 13. Being treated with flucytosine 14. Any patient judged by the investigator to be unfit to participate in the study
Target sample size	35

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

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

Sponsor
Institute	Tottori University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	鳥取県立中央病院（鳥取県）、公立八鹿病院（兵庫県）、独立行政法人国立病院機構米子医療センター（鳥取県）、松江赤十字病院（島根県）、松江市立病院（島根県）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 08 Month 01 Day
Anticipated trial start date	2007 Year 08 Month 01 Day
Last follow-up date	2013 Year 06 Month 03 Day
Date of closure to data entry	2013 Year 06 Month 03 Day
Date trial data considered complete	2013 Year 06 Month 03 Day
Date analysis concluded	2017 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 01 Month 25 Day
Last modified on	2018 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035386