UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058600 |
|---|---|
| Receipt number | R000067004 |
| Scientific Title | A retrospective study to evaluate the tolerability of outpatient initiation of platinum-based combination therapy with carboplatin |
| Date of disclosure of the study information | 2025/07/25 |
| Last modified on | 2025/07/25 18:23:15 |
* 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
A retrospective study to evaluate the tolerability of outpatient initiation of platinum-based combination therapy with carboplatin
Acronym
A retrospective study on the safety of carboplatin-based chemotherapy initiation in outpatient settings
Scientific Title
A retrospective study to evaluate the tolerability of outpatient initiation of platinum-based combination therapy with carboplatin
Scientific Title:Acronym
A retrospective study on the safety of carboplatin-based chemotherapy initiation in outpatient settings
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the tolerability of outpatient initiation of first-line carboplatin-based combination therapy in patients with advanced or recurrent non-small cell lung cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of 4 chemotherapy courses
Key secondary outcomes
Unscheduled medical visit rate up to 4 cycles, Adverse events of grade 3 or higher, Progression-free survival, Overall survival, Dose reduction rate during 4 cycles of treatment
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
Eligible cases are those who meet either (1) or (2) below and also meet (3).
(1) Patients with advanced or recurrent non-small cell lung cancer with a performance status (PS) of 0-1 who have started initial systemic chemotherapy with a regimen containing carboplatin.
(2) Patients with advanced or recurrent non-small cell lung cancer with a PS of 0-1 who have started initial systemic chemotherapy with a regimen containing carboplatin after molecular targeted drug therapy.
(3) Patients who started initial treatment between January 1, 2019 and December 31, 2022.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded.
Those who have expressed refusal to participate in this study through a disclosure document.
Cases in which initial systemic chemotherapy was administered after unplanned emergency hospitalization.
Those treated with the Atezolizumab+Bevacizumab+Carboplatin+Paclitaxel (ABCP) regimen (In reality, it takes more than 5-6 hours to administer the drugs, making it difficult to administer the regimen in an outpatient chemotherapy room. Therefore, it is not possible to compare the outpatient and inpatient groups.)
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Suzuki |
Organization
Chiba University Hospital
Division name
Department of Respiratory medicine
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba
TEL
043-222-7171
suzutaku@chiba-u.jp
Public contact
Name of contact person
| 1st name | Fujihiro |
| Middle name | |
| Last name | Kure |
Organization
Chiba University Hospital
Division name
Department of Respiratory medicine
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba
TEL
043-222-7171
Homepage URL
23fd0146@student.gs.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Funabashi Municipal Medical Center, Chiba Cancer Center Research Institute
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
The Research Ethics Committees of Graduate School of Medicine, Chiba University
Address
1-8-1, Inohana, Chuo-ku, Chiba city, Chiba
Tel
043-222-7171
inohana-rinri@chiba-u.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 | 07 | Month | 25 | 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
344
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
| 2024 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 07 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067004
