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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name