UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of systemic influence by chemotherapy in elderly patients with lung cancer
Title of the study (Brief title)	The study of systemic influence by chemotherapy in elderly patients with lung cancer
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate the systemic influence by chemotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The comparison of the lung, heart, liver,and renal functions before and after chemotherapy
Key secondary outcomes	The assessment of quality of life

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	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. lung cancer patients 2. stage IIIB or IV 3. the patients who recieve chemotherapy in our hospital. 4. adequate organ functions 5. obtained written informed consent
Key exclusion criteria	1. significant severe diseases 2. active infection 3. symptomatic brain metastases 4. mental or psychological disorder 5. history of severe allergic reaction to any medication 6. in pregnancy 7. patients who judged to be inappropriate by the attending doctor
Target sample size	80

Research contact person
Name of lead principal investigator	Tatsuo Kimura
Organization	Osaka City University
Division name	Premier Preventive Medicine
Address	ABENO HARUKAS 21F, 1-1-43, Abenosuji, abeno-ku, Osaka 545-6090 JAPAN
TEL	06-6624-4041
Email	kimutats@med.osaka-cu.ac.jp

Public contact
Name of contact person	Tatsuo Kimura
Organization	Osaka City University
Division name	Premier Preventive Medicine
Address	ABENO HARUKAS 21F, 1-1-43, Abenosuji, abeno-ku, Osaka 545-6090 JAPAN
TEL	06-6624-4041
Homepage URL	http://medcity21.jp/clinic/clinicalresearch.shtml
Email	kimutats@med.osaka-cu.ac.jp

Sponsor
Institute	Premier Preventive Medicine, Graduate School of Medicine, Osaka City University
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	Grant-in-Aid for Scientific Research(S)or(C), Japan Society for the Promotion of Science(JSPS)
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2016 Year 06 Month 05 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 05 Month 30 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date
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	patient accrural period: from July 2016 to March 2022

Management information
Registered date	2016 Year 06 Month 03 Day
Last modified on	2016 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026041