UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044632 |
|---|---|
| Receipt number | R000050982 |
| Scientific Title | A retrospective study of amrubicin monotherapy after combined chemoimmunotherapy for extensive-stage small cell lung cancer(NLCTG2101) |
| Date of disclosure of the study information | 2021/06/23 |
| Last modified on | 2022/06/24 11:26:48 |
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Basic information
Public title
A retrospective study of amrubicin monotherapy after combined chemoimmunotherapy for extensive-stage small cell lung cancer(NLCTG2101)
Acronym
A retrospective study of amrubicin monotherapy after combined chemoimmunotherapy for extensive-stage small cell lung cancer(NLCTG2101)
Scientific Title
A retrospective study of amrubicin monotherapy after combined chemoimmunotherapy for extensive-stage small cell lung cancer(NLCTG2101)
Scientific Title:Acronym
A retrospective study of amrubicin monotherapy after combined chemoimmunotherapy for extensive-stage small cell lung cancer(NLCTG2101)
Region
| Japan |
Condition
Condition
extensive-stage small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Amrubicin therapy is recommended as the standard treatment for recurrent small cell lung cancer, but the therapeutic effect of amrubicin therapy after platinum plus etoposide plus immune checkpoint inhibitor combination therapy is not clear. In this study, we retrospectively evaluated the therapeutic efficacy of amrubicin therapy in the treatment of recurrent small-cell lung cancer after combined chemoimmunotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Response rate, Overall survival, Relationship between time to recurrence and antitumor effect of AMR therapy, Relationship between the occurrence of immune-related adverse events in first-line therapy and the antitumor efficacy and safety of AMR therapy, Relationship between the best treatment effect of first-line therapy and the anti-tumor effect of AMR therapy
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. The patient has been histologically diagnosed with small cell lung cancer.
2. The patient has been diagnosed with extensive-stage small cell lung cancer. Patients with extensive-stage small cell lung cancer or recurrence after radical surgery or radical (chemo)radiation therapy.
3. The patient has received platinum plus etoposide plus immune checkpoint inhibitor combination therapy as initial chemotherapy for advanced small cell lung cancer, and disease progression has been confirmed (including cases in which platinum plus etoposide plus immune checkpoint inhibitor combination therapy was discontinued due to adverse events and disease progression was subsequently observed).
4. AMR monotherapy has been administered as second-line chemotherapy for small cell lung cancer.
Key exclusion criteria
1. Patients deemed inappropriate for enrollment by the principal investigator at each institution
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
9518510
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata City, Niigata Prefecture
TEL
025-368-9325
satoshi7@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Watenabe |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
9518510
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata City, Niigata Prefecture
TEL
025-368-9325
Homepage URL
satoshi7@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata Lung Cancer Treatment Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the Niigata University
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata City, Niigata Prefecture
Tel
025-368-9325
sanonao@adm.niigata-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
新潟肺癌治療研究会
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 23 | 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
30
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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | 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
| 2021 | Year | 06 | Month | 23 | Day |
Last modified on
| 2022 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050982
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