Unique ID issued by UMIN | UMIN000003204 |
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Receipt number | R000003884 |
Scientific Title | UFT maintenance after platinum base adjuvant chemotherapy for resected non-small lung cancer |
Date of disclosure of the study information | 2010/02/17 |
Last modified on | 2017/05/26 13:57:27 |
UFT maintenance after platinum base adjuvant chemotherapy for resected non-small lung cancer
UFT maintenance after complete resection for lung cancer
UFT maintenance after platinum base adjuvant chemotherapy for resected non-small lung cancer
UFT maintenance after complete resection for lung cancer
Japan |
Non-small cell lung cancer
Chest surgery |
Malignancy
NO
To evaluate UFT maintenance after platinum base adjuvant chemotherapy for completely resected non-small lung cancer
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Completion rate of 2-year UFT adminsitration
Safety, disease-free survival duration,overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
UFT daily for 2 years
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically proven non-small lung cancer.
2)Complete resection histologically.
3)Platinum base chemothrapy 1=< courses as prior adjuvant chemotherapy.
4)20 years old or older.
5)Performance status(ECOG)=0-2
6)WBC>=2,000 and <=12,000/mm3
Neutrophil>=1,000mm3
Platlet>=75,000/mm3
T Bil<=1.5mg/dL
AST/ALT<=100 IU/L
PaO2>=70mmHg
7)Written informed consent
1)history of Allergy to UFT
2)History of lung fibrosis or intersittial pneumonistis
3)Active infectious diseases
4)Seviour diarrhea
5)Pre-operation or history of non-platinum adjuvant chemotherapy
6)Concomitant malignancy
7)No match for includion criteria within 8 weeks after prior adjuvant chemotherpy
8)No pregnant or nursing
9)Other uncontrolled medical illness
50
1st name | |
Middle name | |
Last name | Shigeki Sawada |
Shikoku Cancer Center
Thracic surgery
190 Minamiumemotocho-Ko, Matsuyama, Ehime 791-0280, Japan
+81-89-999-1111
ssawada-ths@umin.ac.jp
1st name | |
Middle name | |
Last name | Shigeki Sawada |
Shikoku Cancer Center
Thoracic Surgery
160 Kou, Minamiumemoto-chou, Matsuyama City, Ehime Prefecture
+81-89-999-1111
ssawada-ths@umin.ac.jp
Thracic Surgery
Shikoku Cancer Center
Shikoku Cancer Center
Self funding
NO
2010 | Year | 02 | Month | 17 | Day |
Unpublished
No longer recruiting
2010 | Year | 02 | Month | 17 | Day |
2010 | Year | 02 | Month | 01 | Day |
2010 | Year | 02 | Month | 17 | Day |
2017 | Year | 05 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003884
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