UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer
Title of the study (Brief title)	A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer
Region	Japan

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

Objectives
Narrative objectives1	The objective of this study is to examine the efficacy and safety of combination chemotherapy with S-1 and carboplatin in advanced and recurence non-small 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	Overall survival, Progression free survival 1-year survival 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	CBDCA AUC:5 d1 q4w until PD TS-1 was administered at fixed dose based on the body surface area(BSA) of the patient. BSA<1.25 m2 80mg/day BSA 1.25-1.5 m2 100mg/day BSA>1.5 m2 120mg/day d1-14 q4w until PD
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer (2)Stage III/IV non-small cell lung cancer without any indications for radiotherapy or surgery (3)A measurable lesion according to the Response Evaluation Criteria in Solid Tumors (4) Age:20-74years old (5)ECOG performance status of 0 to 1 (6)With ability of oral intake (7)Adequate organ function, evaluated within 14 days before enrollment (8)Expected to live over 3 months after administration days. (9)Written informed consent from the patients.
Key exclusion criteria	1)Patients with interstitial pneumonia or pulmonary fibrosis on Chest X-ray 2)Patients with pleural or pericardial effusion ,or ascites 3) Patients with active double cancer 4)Patients with significant complications a) Uncontrolled angina pectoris, myocardial infarction, heart failure within 3 months b)Uncontrolled diabetes or hypertension c)Current severe infection, or suspicious of severe infection d) Patients whose participation in the trial is judged to be inappropriate by the attending doctor. (e.g., ileus, bleeding tendency, diarrhea and varicella) 5)Patients with symptomatic brain metastasis 6)Patients with pregnancy or lactation 7) History of serious drug allergy 8) History of serious allergic reaction with CBDCA or other platinum-containing drug 9) History of serious allergic reaction with S-1 10) Being treated with other pyrimidine fluoride antineoplastic agents. 11) Being treated with flucytosine. 12) Any patients judged by the investigator to be unfit to participate in the study
Target sample size	20

Research contact person
Name of lead principal investigator	ogawara mitsumasa
Organization	National Hospital Organization Osaka
Division name	Department of Respiratory Medicine
Address	2-1-14 Hoenzaka, Chou-ku, Osaka 540-0006, Japan
TEL	06-6942-1331
Email	ogawaram@onh.go.jp

Public contact
Name of contact person	ogawara mitsumasa
Organization	National Hospital Organization Osaka
Division name	Department of Respiratory Medicine
Address	2-1-14 Hoenzaka, Chou-ku, Osaka 540-0006, Japan
TEL	06-6942-1331
Homepage URL
Email	ogawaram@onh.go.jp

Sponsor
Institute	National Hospital Organization Osaka
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)

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 03 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 15 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2013 Year 03 Month 07 Day
Last modified on	2018 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011933