UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053483 |
|---|---|
| Receipt number | R000061044 |
| Scientific Title | Cost-effectiveness study of atezolizumab vs. durvalumab : real-world data on first-line chemotherapy combined with immune-checkpoint inhibitors for extensive disease small-cell lung cancer |
| Date of disclosure of the study information | 2024/01/30 |
| Last modified on | 2024/01/30 18:47:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Cost-effectiveness study of atezolizumab vs. durvalumab : real-world data on first-line chemotherapy combined with immune-checkpoint inhibitors for extensive disease small-cell lung cancer
Acronym
cost effectiveness study of chemocherapy combined with immune checkpoint inhivitors for extensive disease small cell lung cancer
Scientific Title
Cost-effectiveness study of atezolizumab vs. durvalumab : real-world data on first-line chemotherapy combined with immune-checkpoint inhibitors for extensive disease small-cell lung cancer
Scientific Title:Acronym
cost effectiveness study of chemocherapy combined with immune checkpoint inhivitors for extensive disease small cell lung cancer
Region
| Japan |
Condition
Condition
extensive disease small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Chemotherapy combined with immune checkpoint inhibitors (Atezolizumab vs. Durvalumab) in the first-line treatment of small cell lung cancer is expected to have roughly the same efficacy based on previous reports, but the associated drug price is higher for Durvalumab, so the cost-effectiveness is thought to be different. The purpose of this study is to clarify the cost-effectiveness of both.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cost effectiveness
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Extensive small cell lung cancer or localized small cell lung cancer that has recurred after surgery or radiation
(2) Atezolizumab combination therapy (CBDCA + ETP + Atezolizumab) or Durvalumab combination therapy (CDDP/CBDCA + ETP + Durvalumab) Treatment was started by December 31st in 2022
Key exclusion criteria
Cases judged by researchers at each institution to be inappropriate for registration.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akito |
| Middle name | |
| Last name | Hata |
Organization
Kobe Minimally Invasive Cancer Center
Division name
Division of Thoracic Oncology
Zip code
6500046
Address
8-5-1,minatojima-nakamachi,Chuouku,Kobe,Hyogo
TEL
0783044100
akitohata@hotmail.com
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Hirano |
Organization
Kobe Minimally Invasive Cancer Center
Division name
Division of Thoracic Oncology
Zip code
6500046
Address
8-5-1,minatojima-nakamachi,Chuouku,Kobe,Hyogo
TEL
0783044100
Homepage URL
tkp_henyas@yahoo.co.jp
Sponsor or person
Institute
Kobe Minimally Invasive Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Healthcare Consulting, inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Minimally Invasive Cancer Center
Address
8-5-1,minatojima-nakamachi,Chuouku,Kobe,Hyogo
Tel
0783044100
tkp_henyas@yahoo.co.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 | 30 | 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
| 2023 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 01 | Month | 30 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061044
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
