UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044048
Receipt number R000050174
Scientific Title Explore research of immunochemotherapy for small cell lung cancer patients; prospective observation study
Date of disclosure of the study information 2021/04/27
Last modified on 2024/07/02 23:06:04

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Basic information

Public title

Explore research of immunochemotherapy for small cell lung cancer patients; prospective observation study

Acronym

Explore research of immunochemotherapy for small cell lung cancer patients; prospective observation study

Scientific Title

Explore research of immunochemotherapy for small cell lung cancer patients; prospective observation study

Scientific Title:Acronym

Explore research of immunochemotherapy for small cell lung cancer patients; prospective observation study

Region

Japan


Condition

Condition

Small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the long-term effectiveness and safety of immunochemotherapy for small cell lung cancer patients in practical setting

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression free survival: PFS

Key secondary outcomes

Time to treatment failure: TTF
Overall survival: OS
Overall response rate; ORR
Disease control rate; DCR
Adverse events including immune related adverse events.


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) Males and females aged 20 years or older, PS: 0-2, with untreated advanced small cell lung cancer who have had a pathological diagnosis of small cell lung cancer confirmed by tumor tissue specimen collection. Patients with chemoradiotherapy can be enrolled if they were diagnosed more than 6 months after the completion of treatment. Concurrent palliative irradiation of the chest is eligible.
2) A patient with evaluable lesions by RECIST (version 1.1).
3) A patient who is to receive immunochemotherapy.
4) A patient who provides written informed consent.

Key exclusion criteria

1) A patient in which evaluation using residual specimens after pathological diagnosis is impossible or difficult.
2) A patient who is judged ineligible to enroll the study by an attending doctor.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Tadaaki
Middle name
Last name Yamada

Organization

University Hospital, Kyoto Prefectural University of Medicine

Division name

Department of pulmonary medicine

Zip code

602-8566

Address

465, Kajii-cho, Kamigyo-ku, Kyoto

TEL

075-251-5513

Email

tayamada@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Morimoto

Organization

University Hospital, Kyoto Prefectural University of Medicine

Division name

Department of pulmonary medicine

Zip code

602-8566

Address

465, Kajii-cho, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5513

Homepage URL


Email

m-kenji@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Review Board of Kyoto Prefectural University of Medicine

Address

602-8566

Tel

075-251-5337

Email

rinri@koto.kpu-m.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

2021 Year 04 Month 27 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

Completed

Date of protocol fixation

2019 Year 11 Month 25 Day

Date of IRB

2019 Year 11 Month 25 Day

Anticipated trial start date

2019 Year 11 Month 25 Day

Last follow-up date

2022 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2024 Year 04 Month 30 Day


Other

Other related information

A multicenter prospective observational study
Eligibility criteria include patients who are to receive immunochemotherapy in a practical setting in each participating institution and those who provide written informed consent.


Management information

Registered date

2021 Year 04 Month 27 Day

Last modified on

2024 Year 07 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050174