Unique ID issued by UMIN | UMIN000008490 |
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Receipt number | R000009981 |
Scientific Title | Phase II study of S-1 monotherapy as 1st line chemotherapy in patients > or = 80 with advanced non-small cell lung cancer |
Date of disclosure of the study information | 2012/08/01 |
Last modified on | 2012/07/21 17:58:58 |
Phase II study of S-1 monotherapy as 1st line chemotherapy in patients > or = 80 with advanced non-small cell lung cancer
Phase II study of S-1 monotherapy as 1st line chemotherapy in patients > or = 80 with advanced non-small cell lung cancer
Phase II study of S-1 monotherapy as 1st line chemotherapy in patients > or = 80 with advanced non-small cell lung cancer
Phase II study of S-1 monotherapy as 1st line chemotherapy in patients > or = 80 with advanced non-small cell lung cancer
Japan |
patients > or = 80 with advanced non-small cell lung cancer
Medicine in general | Pneumology | Surgery in general |
Chest surgery |
Malignancy
NO
To evaluate the efficacy and toxicity of S-1 monotherapy as 1st line chemotherapy in patients > or = 80 with advanced non-small cell lung cancer
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Disease-control rate
Overall survival Progression free survival 1 year survival rate Response rate Time to treatment failure Safety Quality of life
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
S-1 (40-60 mg/body twice per day) on days 1 to 14 of a 21-day cycle until progressive disease.
80 | years-old | <= |
Not applicable |
Male and Female
1) Histological or cytological proven non-small cell lung cancer
2) Locally advanced, metastatic or recurrent non-small cell lung cancer (clinical stage 3A, 3B or 4, according to TNM classification ver 7 for which curative radiotherapy is not indicated.
3) With measurable lesions by RECIST.
4) No prior chemotherapy except EGFR-TKI. Patients who experienced recurrence more than 180 days after completion of postoperative adjuvant chemotherapy with tegafur-uracil capsules/granules (UFT) will be eligible
5) Age of 80 years or older
6) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
7) Life expectancy is more than 12 weeks
8) Adequate organ function shown in physical examinations within 7 days before the registration, as defined below: Neutrophil =>1500/mm3 Platelet count =>100000/mm3 Hemoglobin =>9.0g/dL
AST ALT <= 3 x ULN Total bilirubin <=1.5mg/dL Creatinine <=1.5mg/dL
Creatinine clearance =>40mL/min
SpO2 =>90%
9) Ability to take drugs orally
10) Written informed consent
1) History of severe hypersensitivity drug reaction
2) Prior radiotherapy to the primary tumor except the radiotherapy to the bone metastasis and the brain metastasis.
3) Patients with administration contraindication to S-1
4) Synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval except carcinoma in situ of the cervix and basal type skin cancer
5) Concomitant active infection
6) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis
7) Severe complication(s), e.g., renal failure, hepatic failure, poorly controlled diabetes, or poorly controlled hypertension
8) Distinctly abnormal ECG or cardiovascular disease (heart failure, myocardial infarction, angina)
9) Patients with severe diarrhea
10) Pleural and peritoneal likely to require surgical intervention
11) Symptomatic brain metastasis.
12) Concomitant treatment with flucytosine, phenytoin or warfarin
13) Physician concludes that the patient's participation in this trial is inappropriate
35
1st name | |
Middle name | |
Last name | Tomonobu Koizumi |
Shinshu University Hospital
Comprehensive Cancer Center
3-1-1, Asahi, Matsumoto-shi, Nagano-ken, 390-8621, Japan
1st name | |
Middle name | |
Last name |
Shinshu University School of Medicine
the Comittee for Medical Ethics
Shinshu University Hospital
Shinshu University School of Medicine
Self funding
NO
2012 | Year | 08 | Month | 01 | Day |
Unpublished
Open public recruiting
2012 | Year | 04 | Month | 26 | Day |
2012 | Year | 05 | Month | 01 | Day |
2016 | Year | 04 | Month | 01 | Day |
2012 | Year | 07 | Month | 21 | Day |
2012 | Year | 07 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009981
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