UMIN-CTR Clinical Trial

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 Syunichiro Middle name Last name Iwasawa
Organization	Chiba University Hospital
Division name	Department of Respirology
Zip code	260-8677
Address	1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL	043-226-2575
Email	iwasawas@chiba-u.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
Email	aska_517@icloud.com

Sponsor
Institute	Chiba University
Institute
Department

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 graduate school of medicine, Chiba university
Address	1-8-1 Inohana Chuo-ku, Chiba
Tel	+81-43-222-7171
Email	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	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	Preinitiation
Date of protocol fixation	2020 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date	2021 Year 01 Month 01 Day
Last follow-up date	2023 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	2020 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047797

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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