UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041879 |
|---|---|
| Receipt number | R000047797 |
| Scientific Title | Safety and efficacy of intracranial radiotherapy under immunotherapy against CNS metastases of extensive-stage small cell lung cancer in the real-world setting. |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2022/11/10 19:18:24 |
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Basic information
Public title
Safety and efficacy of intracranial radiotherapy under immunotherapy against CNS metastases of extensive-stage small cell lung cancer in the real-world setting.
Acronym
SERIAL study
Scientific Title
Safety and efficacy of intracranial radiotherapy under immunotherapy against CNS metastases of extensive-stage small cell lung cancer in the real-world setting.
Scientific Title:Acronym
SERIAL study
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examine the safety and efficacy of intracranial radiotherapy under immunotherapy against CNS metastases of extensive-stage small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety(Grade 3 or higher non-hematological toxicity )
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) Age of 20 years old or older
2) Advanced or postoperative recurrence small cell lung cancer
3) Intracranial radiation therapy is planned within 8 weeks after or during the platinum doublet + ICI therapy, or ICI maintenance therapy
4) Consent is obtained in writing regarding participation in this study
Key exclusion criteria
1) The cases which the attending physician has determined ineligible
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Tamiya |
Organization
Osaka International Cancer Institute
Division name
Department of Respirology
Zip code
541-8567
Address
3-1-69,Otemae, Chuo-ku, Osaka, Japan
TEL
06-6945-1181
moto19781205@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Okada |
Organization
Saiseikai Suita Hospital, Osaka
Division name
Department of Respiratory Medicine
Zip code
564-0013
Address
1-2, Kanazono-cho, Suita, Osaka, Japan
TEL
06-6382-1521
Homepage URL
aska_517@icloud.com
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Research ethics committee of the Osaka International Cancer Institute
Address
3-1-69,Otemae, Chuo-ku, Osaka, Japan
Tel
06-6945-1181
rinri01@opho.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
| 2020 | Year | 10 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the safety of intracranial radiotherapy under immunotherapy against CNS metastases examining the Grade 3 or higher non-hematological toxicity
Management information
Registered date
| 2020 | Year | 09 | Month | 24 | Day |
Last modified on
| 2022 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047797
