Unique ID issued by UMIN | UMIN000002035 |
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Receipt number | R000002487 |
Scientific Title | Phase II Study of TS-1 with Patient-Reported Outcome(PRO) Evaluation in Elderly Patients with Advanced NSCLC |
Date of disclosure of the study information | 2009/06/29 |
Last modified on | 2016/06/03 10:05:04 |
Phase II Study of TS-1 with Patient-Reported Outcome(PRO) Evaluation in Elderly Patients with Advanced NSCLC
STEP Clinical Study
Phase II Study of TS-1 with Patient-Reported Outcome(PRO) Evaluation in Elderly Patients with Advanced NSCLC
STEP Clinical Study
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
To assess the efficacy and safety of TS-1 in elderly non-small cell lung cancer patients
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Disease control rate
Progression free survival,Overall survival,Patient-Reported Outcome(PRO),Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
TS-1:60mg/m2/day-80mg/m2/day
75 | years-old | <= |
Not applicable |
Male and Female
1)Japanese
2)Histologically or cytologically Proven non-small cell lung cancer
3)Stage IIIB with no induction radiation therapy,or Stage IV
4)Age range older than 75
5)No previous chemotherapy surgery or radiotherapy
6)Measurable by RECIST criteria
7)Adequate bone narrow,liver, and renal functions
Hb:over9.0g/dl
WBC:4000-12000mm3
Neutro:over2000mm3
PLT:over100000/mm3
T-Bil:underNUMx2
AST,ALT:under100IU
Ccr:over40ml/min
PaO2:over60mmHg
8)ECOG Performance status of 0-2
9)Life expectancy of 12 weeks or more
10)Nomal EKG
11)Written informed concent
1)History of severe allergy
2)Received surgery or radiotherapy to primary region
3)Use of other clinical trial drugs or phenytoin warfarin or flucytosine
4)Serious infection,SIADH,vena cava superior syndrome
5)Serious medical complications
6)Massive pleural effusion,ascites and penicardial effusion requires drainage
7)Symptomatic brain metastasis
8)Require radiotherapy to primary region
9)Concomitant malignancy
10)Intention to be pregnant in the future
11)Other clinical difficulties to this study
40
1st name | |
Middle name | |
Last name | Yasuhiko Nishioka |
Institute of Health Biosciences,The University of Tokushima Graduate School
Department of Respiratory Medicine & Rheumatology
3-18-15 Kuramoto-cho,Tokushima, Tokushima 770-8503, Japan
088-633-7127
yasuhiko@tokushima-u.ac.jp
1st name | |
Middle name | |
Last name | Hisatsugu Goto |
Institute of Health Biosciences,The University of Tokushima Graduate School
Department of Respiratory Medicine & Rheumatology
3-18-15 Kuramoto-cho, Tokushima, Tokushima 770-8503, Japan
088-633-7127
hgoto@tokushima-u.ac.jp
Department of Respiratory Medicine & Rheumatology, Institute of Health Biosciences, The University of Tokushima Graduate School
none
Self funding
NO
2009 | Year | 06 | Month | 29 | Day |
Unpublished
Completed
2009 | Year | 04 | Month | 27 | Day |
2009 | Year | 07 | Month | 01 | Day |
2013 | Year | 05 | Month | 01 | Day |
2009 | Year | 06 | Month | 03 | Day |
2016 | Year | 06 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002487
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