Unique ID issued by UMIN | UMIN000020736 |
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Receipt number | R000023925 |
Scientific Title | The prospective, observational study that paid attention to adjuvant chemotherapy in elderly patients with resection of non-small-cell lung cancer |
Date of disclosure of the study information | 2016/01/27 |
Last modified on | 2021/08/26 16:58:29 |
The prospective, observational study that paid attention to adjuvant chemotherapy in elderly patients with resection of non-small-cell lung cancer
The observational study paid attention to adjuvant chemotherapy in elderly patients with lung cancer (LOGIK1601)
The prospective, observational study that paid attention to adjuvant chemotherapy in elderly patients with resection of non-small-cell lung cancer
The observational study paid attention to adjuvant chemotherapy in elderly patients with lung cancer (LOGIK1601)
Japan |
Non-Small Cell Lung Cancer
Pneumology | Chest surgery |
Malignancy
NO
We prospectively accumulate the non-small-cell lung cancer resection case of the elderly patients (>=75 years) in multi-center, grasp the present conditions of adjuvant chemotherapy (ACT), observe progress after the operations which paid attention to presence or absence of ACT and collect fundamental information about the effectiveness and safety of ACT.
Safety,Efficacy
Baseline change of Karnofsky Performance status score at the time passes 2 years after secondary enrollment
Observational
75 | years-old | <= |
Not applicable |
Male and Female
Eligibility criteria for primary enrollment
1) Age >=75 years (at the registration)
2) Patients with histologically confirmed NSCLC
3) Patients with no prior treatment of chemotherapy or radiation therapy on NSCLC
4) Patients with above pathological stage T1b-IA and complete resection (including R0 (un))
Eligibility criteria for secondary enrollment
1) Patients who received explanation about adjuvant chemotherapy
2) Patients that are able to treat adjuvant chemotherapy within 8 weeks
3) Patients with more than 60% of Karnofsky Performance Status at the registration
1) Patients with active concomitant malignancy in another organs
2) Any other patients who are regarded as unsuitable for this study by the investigators
3) Patients who refused the participation in the research
300
1st name | Tokujiro |
Middle name | |
Last name | Yano |
National Hospital Organization Beppu Medical Center
Department of Thoracic Surgery
874-0011
1473 Ooaza-Uchikamado, Beppu, 874-0011 Japan
0977-67-1111
tokujiro@hosp.go.jp
1st name | Tokujiro |
Middle name | |
Last name | Yano |
National Hospital Organization Beppu Medical Center
Department of Thoracic Surgery
874-0011
1473 Ooaza-Uchikamado, Beppu, 874-0011 Japan
0977-67-1111
tokujiro@hosp.go.jp
Lung Oncology Group in Kyushu, Japan (LOGIK)
Clinical Research Support Center Kyushu
Non profit foundation
JAPAN
Clinical Research Network Fukuoka
3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582 Japan
092-643-7171
mail@crnfukuoka.jp
NO
2016 | Year | 01 | Month | 27 | Day |
Unpublished
345
Completed
2016 | Year | 01 | Month | 18 | Day |
2016 | Year | 01 | Month | 14 | Day |
2016 | Year | 01 | Month | 27 | Day |
2020 | Year | 04 | Month | 30 | Day |
2021 | Year | 03 | Month | 31 | Day |
Study design:
Multi-center prospective cohort observational study
Recruitment method of subjects:
All patients who had a medical examination and meet inclusion criteria
Clinical observation:
Age, gender, height/weight, Karnofsky Performance Status (at enrollment), operation date, pathological stage, tissue-type, having informed consent or not on adjuvant chemotherapy, with or without adjuvant chemotherapy and the regimen in the case with adjuvant chemotherapy
2016 | Year | 01 | Month | 26 | Day |
2021 | Year | 08 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023925
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