UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of gemcitabine and TS-1 in erderly patients with advanced non-small cell lung cancer
Title of the study (Brief title)	Gemcitabine and TS-1 in erderly patients with non-small cell lung cancer
Region	Japan

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

Objectives
Narrative objectives1	To assess the efficacy and safty of gemcitabine and TS-1
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Safty, Overall survival, Progression-free survival

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Gemcitabine and TS-1 chemotherapy
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	70 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)Stage IIIB with no induction of radiation therapy, and Stage IV 3)age range more than 70 years 4)ECOG performance status of 0 or 1 5)a life expectancy of 12 weeks or more 6)Measurable by RECST criteria 7)no previous chemotherapy or radiotherapy 8)adequate bone marrow, liver, and renal functions WBC > 4000 mm-3 Neutro > 2000 mm-3 Platlets > 100000 mm-3 Hb > 9 g dL-1 T-Bil< 1.5 mg dL-1 AST, ALT<100IU/L s-Cr < 1.5 mg dL-1 CCr > 60 mL min-1 PaO2>70torr 9)Written informed consent
Key exclusion criteria	1)Pulmonary fibrosis detectable on chest X-ray films 2)Massive pleural effusion, ascites and pericardial effusion required drainage 3)Concomitant malignancy 4)Serious medical complications: uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure. Uncontrolled diabetes mellitus, hypertension, infection (ileus, bleeding, superior vena cava syndrome 5)Symptomatic brain metastasis 6)Pregnant or milk-feeding female. Intention to be pregnant in the future 7)With severe allergy 8)Other clinical difficulties to this study
Target sample size	40

Research contact person
Name of lead principal investigator	Noriaki Sunaga
Organization	Gunma University Hospital
Division name	Department of Respiratory Medicine
Address	3-39-15 showa-machi, Maebashi, Gunma 371-0014, Japan
TEL	027-220-7111
Email

Public contact
Name of contact person	Noriaki Sunaga
Organization	Gunma University Hospital
Division name	Department of Respiratory Medicine
Address	3-39-15 showa-machi, Maebashi, Gunma 371-0014, Japan
TEL	027-220-7111
Homepage URL
Email	nsunaga@showa.gunma-u.ac.jp

Sponsor
Institute	Gunma University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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	2009 Year 03 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 03 Month 02 Day
Anticipated trial start date	2008 Year 04 Month 01 Day
Last follow-up date	2011 Year 03 Month 01 Day
Date of closure to data entry	2016 Year 03 Month 01 Day
Date trial data considered complete	2016 Year 03 Month 15 Day
Date analysis concluded	2016 Year 03 Month 15 Day

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

Management information
Registered date	2009 Year 03 Month 03 Day
Last modified on	2016 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000002109