UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029576 |
|---|---|
| Receipt number | R000033784 |
| Scientific Title | Efficacy and safety of chemotherapy after PD-1 inhibitors in patients with non-small cell lung cancer: a retrospective multi-institutional analysis (WJOG10217L) |
| Date of disclosure of the study information | 2017/10/20 |
| Last modified on | 2021/10/08 17:13:58 |
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Basic information
Public title
Efficacy and safety of chemotherapy after PD-1 inhibitors in patients with non-small cell lung cancer: a retrospective multi-institutional analysis (WJOG10217L)
Acronym
chemotherapy after PD-1 inhibitors
Scientific Title
Efficacy and safety of chemotherapy after PD-1 inhibitors in patients with non-small cell lung cancer: a retrospective multi-institutional analysis (WJOG10217L)
Scientific Title:Acronym
chemotherapy after PD-1 inhibitors
Region
| Japan |
Condition
Condition
advanced non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this retrospective study is to investigate the efficacy and safety of chemotherapy after PD-1 inhibitors in patients with non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall response rate of cytotoxic chemotherapy including docetaxel (with or without ramucirumab), pemetrexed or S-1
Key secondary outcomes
Progression-free survival, overall survival and safety of cytotoxic chemotherapy including docetaxel (with or without ramucirumab), pemetrexed or S-1
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 confirmed NSCLC
2. Stage III, IV or recurrence after curative radiotherapy or surgery according to the seventh edition of the TNM classification
3. Previously treated with cytotoxic chemotherapy as a first-line
1) Study arm: treated with nivolumab or pembrolizumab as a second-line and subsequently treated with cytotoxic chemotherapy including docetaxel (with or without ramucirumab), pemetrexed or S-1 as a third-line between December 1, 2015 and July 31, 2017
2) Control arm: treated with cytotoxic chemotherapy including docetaxel (with or without ramucirumab), pemetrexed or S-1 as a second-line between April 1, 2014 and July 31, 2017
Key exclusion criteria
None
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Ryoji / Hidetoshi |
| Middle name | |
| Last name | Kato / Hayashi |
Organization
Kindai University Faculty of Medicine
Division name
Department of Medical Oncology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan
TEL
072-366-0221
kato8560@gmail.com
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology 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
Department of Medical Oncology, Kindai University Faculty of Medicine
Address
377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan
Tel
072-366-0221
kato8560@gmail.com
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
| 2017 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1626
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
| 2017 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This retrospective study will be performed based on the patient's clinical records.
Management information
Registered date
| 2017 | Year | 10 | Month | 16 | Day |
Last modified on
| 2021 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033784
