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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044048
Receipt No. 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 2021/04/27

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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
Institute Kyoto Prefectural University of Medicine
Institute
Department

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 Open public recruiting
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

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
2021 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050174

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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