UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058266 |
|---|---|
| Receipt number | R000066610 |
| Scientific Title | Multicenter retrospective study evaluating the efficacy and safety of G-CSF primary prophylaxis in small cell lung cancer patients treated with first-line platinum-etoposide and a PD-L1 inhibitor. TORG-TG2504 |
| Date of disclosure of the study information | 2025/06/24 |
| Last modified on | 2025/06/24 17:38:36 |
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Basic information
Public title
Multicenter retrospective study evaluating the efficacy and safety of G-CSF primary prophylaxis in small cell lung cancer patients treated with first-line platinum-etoposide and a PD-L1 inhibitor. TORG-TG2504
Acronym
Retrospective study evaluating the efficacy and safety of G-CSF primary prophylaxis in the first-line treatment of small cell lung cancer. TORG-TG2504
Scientific Title
Multicenter retrospective study evaluating the efficacy and safety of G-CSF primary prophylaxis in small cell lung cancer patients treated with first-line platinum-etoposide and a PD-L1 inhibitor. TORG-TG2504
Scientific Title:Acronym
Retrospective study evaluating the efficacy and safety of G-CSF primary prophylaxis in the first-line treatment of small cell lung cancer. TORG-TG2504
Region
| Japan |
Condition
Condition
small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy and safety of G-CSF primary prophylaxis in small cell lung cancer patients treated with first-line platinum-etoposide and a PD-L1 inhibitor, through a multicenter, retrospective observational study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
"To compare the incidence of febrile neutropenia (FN) with and without primary prophylaxis using G-CSF, point estimates will be calculated after applying inverse probability weighting. Between-group comparisons will be conducted using weighted logistic regression analysis. Robust variance estimation will be employed to estimate the variance of the odds ratios. For the cohort after propensity score matching, between-group comparisons will be performed using the chi-square test.
Key secondary outcomes
Mortality, unscheduled outpatient visit rate, emergency hospitalization rate related to febrile neutropenia. Overall survival. Progression-free survival. Objective response rate. Mean relative dose intensity. Incidence of adverse events.
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) Patients diagnosed with small cell lung cancer by histological or cytological examination.
2) Patients with extensive-stage small cell lung cancer, or patients who experienced recurrence after chemoradiotherapy for limited-stage small cell lung cancer.
3) Patients who received first-line treatment with one of the following regimens between September 1, 2019 and December 31, 2023
Carboplatin/etoposide/atezolizumab
Carboplatin/etoposide/durvalumab
Cisplatin/etoposide/durvalumab
4)Patients who received the first cycle of first-line treatment with
Carboplatin at AUC over 5
Cisplatin at over 75 mg/m2
Etoposide at over 80 mg/m2
5)Patients aged 18 years or older at the start of treatment.
Key exclusion criteria
1) Patients deemed inappropriate for inclusion in the study by the site investigator responsible for data collection.
2) Patients who refused to participate in this study via the opt-out process.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Shuhei |
| Middle name | |
| Last name | Teranishi |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
2410815
Address
2-3-2, Nakao, Yokohama Shi Asahi Ku, Kanagawa Ken
TEL
0455202222
teranishi.shu.su@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Teranishi |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
2410815
Address
2-3-2, Nakao, Yokohama Shi Asahi Ku, Kanagawa Ken
TEL
0455202222
Homepage URL
teranishi.shu.su@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama Municipal Citizen's Hospital
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
Kanagawa Cancer Center
Address
2-3-2, Nakao, Yokohama Shi Asahi Ku, Kanagawa Ken
Tel
0455202222
clinical_trials@kcch.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
| 2025 | Year | 06 | Month | 24 | 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
250
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
| 2025 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 06 | Month | 24 | Day |
Last modified on
| 2025 | 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=R000066610
