Unique ID issued by UMIN | UMIN000003223 |
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Receipt number | R000003786 |
Scientific Title | Feasibility study of UFT after surgery with platinum based adjuvant chemotherapy in completely resected pathological stage II/IIIA non-small cell lung cancer |
Date of disclosure of the study information | 2010/02/22 |
Last modified on | 2013/09/24 13:46:56 |
Feasibility study of UFT after surgery with platinum based adjuvant chemotherapy in completely resected pathological stage II/IIIA non-small cell lung cancer
Platinum based adjuvant chemotherapy followed by maintenance UFT in non-small cell lung cancer
Feasibility study of UFT after surgery with platinum based adjuvant chemotherapy in completely resected pathological stage II/IIIA non-small cell lung cancer
Platinum based adjuvant chemotherapy followed by maintenance UFT in non-small cell lung cancer
Japan |
completely resected pathological stage II/IIIA non-small cell lung cancer
Chest surgery |
Malignancy
NO
To evaluate the feasibility study of UFT after surgery with platinum based in completely resected pathological stage II/IIIA non-small cell lung cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Feasibility, relative performance
relapse-free survival , Overall survival , safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Platinum based adjuvant chemotherapy followed by maintenance UFT for 2 years. UFT is administered orally at 320mg/m2/day for 2 years consecutive day.
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) Pathologically-proven non-small cell lung cancer
2) pathological stage II,IIIA
3) completely resected NSCLC
4) completely resected by at least lobectomy
5) LN dissection (ND2a) or Elective Lymph Node Dissection
6) Without previous therapy for non-small cell lung cancer
7) PS 0 or 1
8) age 20-80
9) adequate organ function
WBC >=4,000/mm3 and <=12,000/mm3
neutrophil >=2,000/mm3
Hb >=10.0g/dl
Plt >=100,000/mm3
T-bil <=1.2mg/dl
AST/ALT <=100IU/L
Ccr >=60mL/min(Cockcroft-Gault)
PaO2 >=70mmHg or SpO2 >=95%
10) possible to receive platinumu based chemotherapy within 10 weeks after surgery
11) written informed consent
1) not recovered from surgical complications
2) active infection such as bacterial infection
3) patients with interstitial pneumonaitis or pulmonary fibrosis, as determined by chest CT
4) patients with myocardial infraction within 6 months
5) patients with uncontroled complications
6) grade 2 or greater peripheral neuropathy
7) Active another neoplasm
8) pregnant or lactating women
9) concomitant therapy with other fluoropyrimmidine
10) pneumonectomy
11) Patient who is judged to be inappropriate as subject to this study by the principal investigator
25
1st name | |
Middle name | |
Last name | Atsushi Mochizuki |
St.Marianna University School of Medicine
Division of Chest Surgery
2-16-1 Sugao, Miyamae-ku, Kawasaki-city, Kanagawa
044-977-8111
a2mochi@marianna-u.ac.jp
1st name | |
Middle name | |
Last name | Atsushi Mochizuki |
St.Marianna University School of Medicine
Division of Chest Surgery
2-16-1 Sugao, Miyamae-ku, Kawasaki-city, Kanagawa
044-977-8111
a2mochi@marianna-u.ac.jp
Department of Surgery, Division of Chest Surgery, St.Marianna University School of Medicine
None
Other
NO
聖マリアンナ医科大学病院(神奈川県)
2010 | Year | 02 | Month | 22 | Day |
Unpublished
Terminated
2010 | Year | 01 | Month | 05 | Day |
2010 | Year | 02 | Month | 01 | Day |
2017 | Year | 02 | Month | 01 | Day |
2010 | Year | 02 | Month | 21 | Day |
2013 | Year | 09 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003786
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