UMIN-CTR Clinical Trial

Basic information
Public title	A medical economic analysis of cancer chemotherapy for patients with advanced lung cancer.
Acronym	Medical economic analysis of chemotherapy for patients with advanced lung cancer.
Scientific Title	A medical economic analysis of cancer chemotherapy for patients with advanced lung cancer.
Scientific Title:Acronym	medical economic analysis of chemotherapy for patients with advanced lung cancer.
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Calculate the cost of 1st-line or 2nd-line chemotherapy including molecular target drugs, angiogenesis inhibitors and immune checkpoint inhibitors for improving prognosis in patients with advanced lung cancer. Then compare cost-effectiveness between each drug, and search for appropriate cancer chemotherapy medical economically.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	compare incremental cost effectiveness ratio between each drug as 1st-line or 2nd-line chemotherapy including molecular target drugs, angiogenesis inhibitors and immune checkpoint inhibitors for improving prognosis in patients with advanced lung cancer.
Key secondary outcomes	search for appropriate treatment in cost-effectiveness for patients with advanced lung cancer, according to each of histopathological type, driver mutation and expression of PD-L1.

Base
Study type	Others,meta-analysis etc

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Between June, 2020 to December, 2022, anti-cancer drugs for patients with lung cancer has been approved by Ministry of Health, Labor and Welfare, JAPAN
Key exclusion criteria	Between June, 2020 to December, 2022, anti-cancer drugs for patients with lung cancer hasn't been approved yet, or rescission of approval by Ministry of Health, Labor and Welfare, JAPAN
Target sample size

Research contact person
Name of lead principal investigator	1st name takeshi Middle name Last name tamaki
Organization	Kansai medical university
Division name	First Department of Internal Medicine
Zip code	570-8507
Address	Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL	0669921001
Email	tamakit@takii.kmu.ac.jp

Public contact
Name of contact person	1st name Takeshi Middle name Last name Tamaki
Organization	Kansai Medical University Medical Center
Division name	First Department of Internal Medicine
Zip code	570-8507
Address	Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL	0669921001
Homepage URL
Email	tamakit@takii.kmu.ac.jp

Sponsor
Institute	kansai medical university
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Ethics Review Board of Kansai Medical University Medical Center
Address	Fumizono-cho 10-15, Moriguchi-city, Osaka.
Tel	0669921001
Email	rinriirb@hirakata.kmu.ac.jp

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	2020 Year 11 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2020 Year 04 Month 20 Day
Date of IRB	2020 Year 05 Month 12 Day
Anticipated trial start date	2020 Year 11 Month 24 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry	2024 Year 04 Month 30 Day
Date trial data considered complete	2024 Year 10 Month 31 Day
Date analysis concluded

Other
Other related information	I simulate it using an imaginary patient model without intending for a real patient in this study. The dose of the anti-cancer drug calculates using a patient model.

Management information
Registered date	2020 Year 11 Month 24 Day
Last modified on	2022 Year 08 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048554