UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050630 |
|---|---|
| Receipt number | R000057605 |
| Scientific Title | Rechallenge chemotherapy with carboplatin plus paclitaxel or nab-paclitaxel for patients with non-small-cell lung cancer and interstitial lung disease |
| Date of disclosure of the study information | 2023/03/20 |
| Last modified on | 2025/04/18 15:30:06 |
* 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
Rechallenge chemotherapy with carboplatin plus paclitaxel or nab-paclitaxel for patients with non-small-cell lung cancer and interstitial lung disease
Acronym
Rechallenge chemotherapy with CBDCA+PTX/nab-PTX for patients with NSCLC and ILD
Scientific Title
Rechallenge chemotherapy with carboplatin plus paclitaxel or nab-paclitaxel for patients with non-small-cell lung cancer and interstitial lung disease
Scientific Title:Acronym
Rechallenge chemotherapy with CBDCA+PTX/nab-PTX for patients with NSCLC and ILD
Region
| Japan |
Condition
Condition
Patients with non-small-cell lung cancer and interstitial lung disease
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to assess the efficacy of rechallenge chemotherapy with carboplatin plus paclitaxel or nab-paclitaxel for patients with non-small-cell lung cancer and interstitial lung disease who were previously treated with the same regimen.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall response rate
Key secondary outcomes
Overall survival, Progression-free survival, Disease control rate, Safety
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) Histologically or cytologically proven NSCLC
2) Unresectable advanced or recurrent NSCLC
3) Patients with interstitial lung disease diagnosed by computed tomography before the first line of chemotherapy
4) Patients who had received CBDCA+PTX/nab-PTX as a first-line chemotherapy
5) Patients who had received CBDCA+PTX/nab-PTX rechallenge in late line chemotherapy between January 2018 and December 2022.
Key exclusion criteria
Disagree to study registration
Target sample size
24
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 | Taku |
| Middle name | |
| Last name | Itoh |
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
titoh@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, Kanagawa Cardiovascular and Respiratory Center, Kinki-Chuo Chest Medical Center
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
| 2023 | Year | 03 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057605
