UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006393 |
|---|---|
| Receipt number | R000007568 |
| Scientific Title | Cross-sectional study of second-line therapy administration after platinum-based chemotherapy for patients with advanced NSCLC. |
| Date of disclosure of the study information | 2011/09/22 |
| Last modified on | 2020/08/19 13:55:24 |
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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
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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
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/
info@csp.or.jp
Sponsor or person
Institute
SAPPHIRE Executive committee
Institute
Department
Personal name
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
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
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Management information
Registered date
| 2011 | Year | 09 | Month | 22 | Day |
Last modified on
| 2020 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007568
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| Registered date | File name |
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| Registered date | File name |
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