UMIN-CTR Clinical Trial

Basic information
Public title	Cross-sectional study of second-line therapy administration after platinum-based chemotherapy for patients with advanced NSCLC.
Acronym	Second-line chemotherapy administration for patients with advanced NSCLC, who completed platinum-based "Hyojun" (standard) doublet, In the follow-up period, and at recurrence.(SAPPHIRE)
Scientific Title	Cross-sectional study of second-line therapy administration after platinum-based chemotherapy for patients with advanced NSCLC.
Scientific Title:Acronym	Second-line chemotherapy administration for patients with advanced NSCLC, who completed platinum-based "Hyojun" (standard) doublet, In the follow-up period, and at recurrence.(SAPPHIRE)
Region	Japan

Condition
Condition	Advanced lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the proportion of the second-line therapy administration after platinum-based chemotherapy for patients with advanced NSCLC, and explore the reasons and the background factors of the patients who could not take the second-line therapy. We also discuss the strategy for the follow-up of patients after the first-line chemotherapy (maintenance chemotherapy, periodical follow-up without continuing chemotherapy), by comparing the background factors at the beginning of the first and second line chemotherapy.
Basic objectives2	Others
Basic objectives -Others	horyuu
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Proportion of the patients administered the second-line chemotherapy
Key secondary outcomes	1)Proportion of the patients who had PD for first-line chemotherapy 2)Proportion of the patients who were administered second-line chemotherapy 3)Proportion of the patients who were administered third-line chemotherapy after the second-line chemotherapy 4)Proportion of the patients who were administered second-line chemotherapy after having PD for first-line chemotherapy. 5)Proportion of the patients who were administered second-line chemotherapy after taking maintenance chemotherapy.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients who were diagnosed as advanced or recurrent NSCLC before this study. 2)Consecutive patients in each institution who had started first-line platinum chemotherapy in combination with third generation agent after April 1, 2010.
Key exclusion criteria	1)Recurrent NSCLC patients who had undergone adjuvant platinum based chemotherapy. 2)Active double cancer.
Target sample size	750

Research contact person
Name of lead principal investigator	1st name Hideo Middle name Last name Kunitoh
Organization	Mitsui Memorial Hospital
Division name	Department of Respiratory Medicine
Zip code	101-8643
Address	1,Kanndaizumi-chou, Chiyoda-ku, Tokyo, 101-8643, Japan
TEL	03-3862-9111
Email	no@mail

Public contact
Name of contact person	1st name Akira Middle name Last name Yamao
Organization	Public Health Research Foundation
Division name	Comprehensive Support Project for Clinical Research
Zip code	169-0051
Address	1-1-7, Nishiwaseda, Shinjuku-ku, Tokyo, 169-0051, Japan
TEL	03-5287-2633
Homepage URL	http://www.csp.or.jp/
Email	info@csp.or.jp

Sponsor
Institute	SAPPHIRE Executive committee
Institute
Department

Funding Source
Organization	Public Health Research Foundation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	no
Address	no
Tel	no
Email	nomail

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	2011 Year 09 Month 22 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	No longer recruiting
Date of protocol fixation	2010 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	horyuu

Management information
Registered date	2011 Year 09 Month 22 Day
Last modified on	2020 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007568