Unique ID issued by UMIN | UMIN000033574 |
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Receipt number | R000038286 |
Scientific Title | A validation study of biomarkers to predict responders to non-pharmacological multimodal program for advanced cancers |
Date of disclosure of the study information | 2019/03/31 |
Last modified on | 2023/02/25 10:01:11 |
A validation study of biomarkers to predict responders to non-pharmacological multimodal program for advanced cancers
NEXTAC-Three
A validation study of biomarkers to predict responders to non-pharmacological multimodal program for advanced cancers
NEXTAC-Three
Japan |
Non-small-cell lung and pancreatic cancer
Medicine in general | Hepato-biliary-pancreatic medicine | Pneumology |
Hematology and clinical oncology |
Malignancy
NO
To varidate usefulness of biomarkers to predict responders to non-pharmacological multimodal program (NEXTAC program)
Efficacy
Confirmatory
Explanatory
Phase II
Positive predictive value
Sensitivity
Specificity
Negative predictive value
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Behavior,custom | Other |
1. nutritional couseling
2. home-based exercise intervention
3. physical activity intervention
70 | years-old | <= |
Not applicable |
Male and Female
1) >=70 years old and ECOG-PS 0-2
2) newly diagnosed NSCLC/pancreatic cancer in stage III, IV, or post-operative recurrence.
3) They are planned to receive the first-line systemic chemotherapy
4) Having written informed consent
5) More than 3 months of survival was expected
1) Having disabilities according to the modified KATZ index
2) Having high risks for safe physical assessments and interventions (e.g. Unstable cardiac diseases, Severely symptomatic brain or bone mets, severe phyciatric disease, etc)
3) Having difficulties in swallowing, digesting, and absorbing food
100
1st name | Koichi |
Middle name | |
Last name | Takayama |
Kyoto Prefectual University of Medicine
Department of Respirology
602-8566
Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN
075-251-5513
takayama@koto.kpu-m.ac.jp
1st name | Tateaki |
Middle name | |
Last name | Naito |
Shizuoka Cancer Center
Division of thoracic oncology
411-8777
1007 Shimnagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
055-989-5222
t.naito@scchr.jp
Department of Respirology, Kyoto Prefectual University of Medicine
Japan Agency for Medical Research and Development
Japanese Governmental office
Japan
Shizuoka Cancer Center
1007 Shimonagakubo, Nagaizumi, Sunto, Shizuoka
0559895222
t.naito@scchr.jp
NO
2019 | Year | 03 | Month | 31 | Day |
Unpublished
80
Delay expected |
under review
No longer recruiting
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2021 | Year | 03 | Month | 31 | Day |
2018 | Year | 07 | Month | 31 | Day |
2023 | Year | 02 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038286
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