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 |
Explore research of immunochemotherapy for small cell lung cancer patients; prospective observation study
Explore research of immunochemotherapy for small cell lung cancer patients; prospective observation study
Explore research of immunochemotherapy for small cell lung cancer patients; prospective observation study
Explore research of immunochemotherapy for small cell lung cancer patients; prospective observation study
Japan |
Small cell lung cancer
Pneumology |
Malignancy
NO
To assess the long-term effectiveness and safety of immunochemotherapy for small cell lung cancer patients in practical setting
Efficacy
Progression free survival: PFS
Time to treatment failure: TTF
Overall survival: OS
Overall response rate; ORR
Disease control rate; DCR
Adverse events including immune related adverse events.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
50
1st name | Tadaaki |
Middle name | |
Last name | Yamada |
University Hospital, Kyoto Prefectural University of Medicine
Department of pulmonary medicine
602-8566
465, Kajii-cho, Kamigyo-ku, Kyoto
075-251-5513
tayamada@koto.kpu-m.ac.jp
1st name | Kenji |
Middle name | |
Last name | Morimoto |
University Hospital, Kyoto Prefectural University of Medicine
Department of pulmonary medicine
602-8566
465, Kajii-cho, Kamigyo-ku, Kyoto, Japan
075-251-5513
m-kenji@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine
None
Other
Ethics Review Board of Kyoto Prefectural University of Medicine
602-8566
075-251-5337
rinri@koto.kpu-m.ac.jp
NO
2021 | Year | 04 | Month | 27 | Day |
Unpublished
Completed
2019 | Year | 11 | Month | 25 | Day |
2019 | Year | 11 | Month | 25 | Day |
2019 | Year | 11 | Month | 25 | Day |
2022 | Year | 10 | Month | 31 | Day |
2024 | Year | 04 | Month | 30 | Day |
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.
2021 | Year | 04 | Month | 27 | Day |
2024 | Year | 07 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050174