UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Chemotherapy in Japanese advanced lung cancer patients: a descriptive study using database
Title of the study (Brief title)	Chemotherapy in advanced lung cancer patients: a descriptive study
Region	Japan

Condition
Condition	Advanced lung cancer
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Describe the detail of chemotherapy regimens for advanced lung cancer patients in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The proportion of each chemotherapy regimen.
Key secondary outcomes	Overall survival, costs, adverse events of each chemotherapy regimen.

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

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	-Diagnosed with C34 in International Classification of Diseases, 10th revision (ICD-10) between 2004/1-2014/9 -Stage IIIB or IV
Key exclusion criteria	-18> -Received thoracic radiotherapy within 8 days of 1st chemotherapy -If they had any previously diagnosed cancers -Did not survive at least 30 days past diagnosis
Target sample size	1000

Research contact person
Name of lead principal investigator	KATAOKA Yuki
Organization	Graduate School of Medicine and Public Health, Kyoto University
Division name	Department of Healthcare Epidemiology
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto, JAPAN
TEL	075-753-4645
Email	youkitikk@gmail.com

Public contact
Name of contact person	KATAOKA Yuki
Organization	Graduate School of Medicine and Public Health, Kyoto University
Division name	Department of Healthcare Epidemiology
Address	Yoshida Konoe-cho, Sakyo-ku, Kyoto, JAPAN
TEL	075-753-4645
Homepage URL
Email	youkitikk@gmail.com

Sponsor
Institute	Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
Institute
Department

Funding Source
Organization	Department of Healthcare Epidemiology, Graduate School of Medicine and Public Health, Kyoto University
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	2015 Year 02 Month 02 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 02 Month 02 Day
Anticipated trial start date	2015 Year 02 Month 02 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	Data extracted from database are birth date, gender, department, institution, Brinkman index, insurance, postal cord, height, weight, performance status, ICD-10 codes, EGFR mutation status, Alk mutation status, TNM, ADL score, comorbidity, white blood cells, neutrophil, hemoglobin, platelet, bilirubin, AST, ALT, BUN, creatinin, albumin, tested date, date administered chemotherapy, prescription of gefitinib, erlotinib, afatinib, S-1, UFT, crizotinib, alectinib, death date, and last admission date.

Management information
Registered date	2015 Year 02 Month 02 Day
Last modified on	2018 Year 01 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019067