UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053134 |
|---|---|
| Receipt number | R000060639 |
| Scientific Title | A multicenter retrospective study to evaluate the efficacy and safety of platinum-based chemotherapy in combination with immunotherapy for extensive-stage small cell lung cancer in the real-world setting |
| Date of disclosure of the study information | 2024/01/20 |
| Last modified on | 2023/12/17 15:37:27 |
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Basic information
Public title
A multicenter retrospective study to evaluate the efficacy and safety of platinum-based chemotherapy in combination with immunotherapy for extensive-stage small cell lung cancer in the real-world setting
Acronym
Efficacy and safety of combination-immunotherapy for ES-SCLC
Scientific Title
A multicenter retrospective study to evaluate the efficacy and safety of platinum-based chemotherapy in combination with immunotherapy for extensive-stage small cell lung cancer in the real-world setting
Scientific Title:Acronym
Efficacy and safety of combination-immunotherapy for ES-SCLC
Region
| Japan |
Condition
Condition
extensive-stage small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the efficacy and safety of platinum-based chemotherapy in combination with immunotherapy for extensive-stage small cell lung cancer in the real-world setting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival (Patients with platinum-based chemotherapy in combination with immunotherapy and Patients with platinum-based chemotherap)
Key secondary outcomes
Progression free survival
Objective response rate
1 year-OS, 2 year-OS
Safety(severe toxicity)
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Extensive-stage small cell lung cancer
Patients who received first-line platinum-based chemotherapy in combination with immunotherapy and Patients who received first-line platinum-based chemotherapy
Key exclusion criteria
Patients who are judged by the attending doctor as inappropriate to participate in this clinical research
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Sonehara |
Organization
Shinshu University School of Medicine
Division name
First Department of Internal Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto city, Nagano
TEL
0263-37-2631
soneponpon@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Sonehara |
Organization
Shinshu University School of Medicine
Division name
First Department of Internal Medicine
Zip code
390-8631
Address
3-1-1, Asahi, Matsumoto city, Nagano
TEL
0263-37-2631
Homepage URL
soneponpon@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
None
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
Shinshu University School of Medicine
Address
3-1-1, Asahi, Matsumoto city, Nagano
Tel
0263-37-2631
soneponpon@shinshu-u.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
| 2024 | Year | 01 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A multicenter retrospective study
Management information
Registered date
| 2023 | Year | 12 | Month | 17 | Day |
Last modified on
| 2023 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060639
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
