Unique ID issued by UMIN | UMIN000011694 |
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Receipt number | R000013671 |
Scientific Title | Feasibility Study on Adjuvant Calboplatin and S-1 in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer |
Date of disclosure of the study information | 2013/09/11 |
Last modified on | 2014/12/02 18:20:18 |
Feasibility Study on Adjuvant Calboplatin and S-1 in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer
Feasibility Study on Adjuvant Calboplatin and S-1 in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer
Feasibility Study on Adjuvant Calboplatin and S-1 in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer
Feasibility Study on Adjuvant Calboplatin and S-1 in patients with completely resected stage II-IIIA Non-Small Cell Lung Cancer
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
To evaluate the feasibility of carboplatiun and s-1 as adjuvant chemotherapy in patients with completely resected stage II-IIIa non-small cell lung cancer
Safety,Efficacy
Exploratory
Phase II
Accomplishment of 3 course treatment
Safty, 2yr RFS
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Carboplatin AUC 5 is administered by an infusion lasting 60 minutes on day 1 and S-1 is administered twice a day on day1-14. Every 3 weeks for 4 courses
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Histologically or cytologically determined non-small cell lung cancer.
2) Pathological stageIIA, IIB, IIIA. Completely resected.
3) Neither previous chemotherapy nor radiotherapy before operation.
4) ECOG performance status 0 or 1.
5) Aged 20-75 years old.
6) Adequate organ function.
White blood cell count >= 4,000 /mm3
Neutrophil count >= 1,500 /mm3
Hemoglobin >= 9.0 g/dL
Platelet count >= 100,000 /mm3
AST and ALT <= 100 IU/L
Total bilirubin <or= 1.5 mg/dL
Serum creatinine <= 1.25 mg/dL
PaO2 >= 60.0 torr
7) Patients are excepted to live at least 3 months
8) Written informed consent
1) Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
2) Severe concurrent disease (Ischemic heart disease requiring treatment, hepatic failure, controlled diabetes, infection, psychiatric disorder).
3) Patients who are pregnant,considering pregnancy oractaing.
4) Receiving systemic treatment of steroid or immunosuppressant.
5) History of active double cancerwithin 5years prior to the study.
6) Other conditions not suitable forthis study.
25
1st name | |
Middle name | |
Last name | Takeshi Morimoto |
Hirosaki University Graduate School of Medicine
Department of Cardiology, Respiratory Medicine and Nephrology
5 Zaifu-cho, Hirosaki, Aomori, 036-8562 Japan
0172-39-5057
moritaka@cc.hirosaki-u.ac.jp
1st name | |
Middle name | |
Last name | Hisashi Tanaka |
Hirosaki University Graduate School of Medicine
Department of Cardiology, Respiratory Medicine and Nephrology
5 Zaifu-cho, Hirosaki, Aomori, 036-8562 Japan
0172-39-5057
h-tanaka@cc.hirosaki-u.ac.jp
Hirosaki University Graduate School of Medicine
None
Self funding
NO
弘前大学附属病院(青森県),弘前中央病院(青森県),国立病院機構弘前病院(青森県)
2013 | Year | 09 | Month | 11 | Day |
Unpublished
Terminated
2012 | Year | 06 | Month | 27 | Day |
2012 | Year | 07 | Month | 01 | Day |
2013 | Year | 09 | Month | 10 | Day |
2014 | Year | 12 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013671
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