UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046002 |
|---|---|
| Receipt number | R000052421 |
| Scientific Title | Efficacy and safety of immune checkpoint inhibitors alone or in combination with chemotherapy in metastatic pulmonary sarcomatoid carcinoma: a retrospective cohort study |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2022/11/08 15:26:02 |
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Basic information
Public title
Efficacy and safety of immune checkpoint inhibitors alone or in combination with chemotherapy in pulmonary sarcomatoid carcinoma
Acronym
Efficacy and safety of immune checkpoint inhibitors alone or in combination with chemotherapy in pulmonary sarcomatoid carcinoma
Scientific Title
Efficacy and safety of immune checkpoint inhibitors alone or in combination with chemotherapy in metastatic pulmonary sarcomatoid carcinoma: a retrospective cohort study
Scientific Title:Acronym
Efficacy and safety of immune checkpoint inhibitors alone or in combination with chemotherapy in metastatic pulmonary sarcomatoid carcinoma: a retrospective cohort study
Region
| Japan |
Condition
Condition
Pulmonary sarcomatoid carcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of immune checkpoint inhibitors(ICI) alone or in combination with chemotherapy in metastatic pulmonary sarcomatoid carcinoma(PSC).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Response Rate, Progression Free Survival
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with histologically or cytologically proven PSC
(2) Patients with stage IIIB/IIIC/IV or postoperative recurrence
(3) Patients who received ICI alone or in combination with chemotherapy
(4) Patients aged 20 years or older at the time of diagnosis
Key exclusion criteria
(1)Patients who chose not to participate in the study
(2)Patients who received ICI as previous therapy
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Tachihara |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe City
TEL
078-382-5660
mt0318@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hazama |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe City
TEL
078-382-5660
Homepage URL
dhazama@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
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
Kobe University Hospital Clinical and Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City
Tel
078-382-6669
kansatsu@med.kobe-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 01 | 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
124
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
| 2021 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 05 | Month | 17 | Day |
Date analysis concluded
Other
Other related information
1)
Age, Sex, ECOG PS, Histopathological subtype, Method of diagnosis, Genomic alterations, Clinical staging, PD-L1 expression, Smoking status, Autoimmune diseases, Steroids or immunosuppressive agents at treatment initiation, History of thoracic radiotherapy
2)
CT, MRI and PET-CT before treatment, Measurable lesion, Brain metastases, Liver metastases, Interstitial lung disease
3)
Treatment regimen, Date of treatment initiation, Best over-all response, Date of best response, The last date of progression free follow-up, Date of treatment discontinuation, Reason for treatment discontinuation, Incidence and the worst grade of Immune-related Adverse Drug Reaction, The last date of survival follow-up, cause of death
Management information
Registered date
| 2021 | Year | 11 | Month | 07 | Day |
Last modified on
| 2022 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052421
