Unique ID issued by UMIN | UMIN000010989 |
---|---|
Receipt number | R000012863 |
Scientific Title | Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Previously Treated Non-small Cell Lung Cancer |
Date of disclosure of the study information | 2013/06/18 |
Last modified on | 2018/12/23 12:44:19 |
Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Previously Treated Non-small Cell Lung Cancer
Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Previously Treated Non-small Cell Lung Cancer
Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Previously Treated Non-small Cell Lung Cancer
Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Previously Treated Non-small Cell Lung Cancer
Japan |
Non-small Cell Lung Cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To evaluate efficacy and safety of alternate-day administration of S-1 plus carboplatin in elderly patients with previously treated non-small cell lung cancer
Safety,Efficacy
Exploratory
Phase II
Progression-free survival
Response rate, safety and adverse event, 1-year survival rate, overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Induction chemotherapy with alternate-day administration of S-1 (80mg/m2/day on Mon, Wed, Fri, and Sun) plus carboplatin at the dose of area under the curve 5 (Day 1) every 3 weeks, up to 4 cycles.
Continuation maintenance chemotherapy with alternate-day administration of S-1 (80mg/m2/day on Mon, Wed, Fri, and Sun) until PD is observed.
75 | years-old | <= |
Not applicable |
Male and Female
1) Age of 75 years or older
2) Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
3) Incurable NSCLC with stage IIIB or stage IV
4) Patients with NSCLC previously treated with platinum-based chemotherapy within two regimens, or three regimens including EGFR-TKI (Gefitinib or Erlotinib). In both cases, platinum-based chemotherapy must have been delivered before single agent cytotoxic chemotherapy.
In patients who have undergone thoracic surgery and platinum-based adjuvant chemotherapy, platinum-based adjuvant chemotherapy could be considered as first line chemotherapy when the recurrence is observed within 12 months after surgery.
Patients who have undergone chemoradiotherapy have to be excluded.
Patients who have received two regimens of platinum-based chemotherapy have to be excluded.
5) Performance Status (Eastern Cooperative Oncology Group: ECOG) 0-2
6) Both measurable and non-measurable lesions are acceptable as far as objective lesions are detectable by means of X-ray, CT, MRI, and RI within 28days before the entry.
7) Capable of oral intake
8) Adequate organ functions within 14 days before the entry
i) White blood cell count 3500/mm3 or over
ii) Neutrophil count 1500/mm3 or over
iii) Platelet count 100,000/m3 or over
iv) Hemoglobin 9.0g/dL or over
v) Total bilirubin 2.0mg/dL or under
vi) AST/ALT 100IU/L or under
vii) PaO2 60Torr or over, or SpO2 90% or over
viii) Creatinine clearance 50mL/min or over
9) Estimated life expectancy of at least 12 weeks
10) With written informed consent
1) Past history of severe drug hypersensitivity
2) Severe bone marrow suppression, renal dysfunction, or liver dysfunction
3) Treatment history of S-1, except for the cases in which S-1 had been administered as adjuvant chemotherapy and recurrence was observed more than 1 year after thoracic surgery
4) Active double cancer within 5 years of disease-free interval, except for curable lesions like carcinoma in situ and mucosal cancer
5) Severe complication such as ileus, interstitial pneumonia, uncontrolled diabetes, heart failure, renal dysfunction, liver dysfunction, active digestive ulcer, and acute myocardial infarction or angina pectoris within six months
6) Diarrhea graded 2 or more
7) Active infectious disease in need of systemic administration of antibiotics
8) Uncontrolled pleural effusion, ascites, and pericardial effusion which needs drainage
9) Uncontrolled symptomatic brain metastasis
10) Systemic administration of steroid
11) Patients with psychiatric disease or symptoms, who seem to have difficulty in participating in the study
12) Any patients judged by the investigator to be unfit to participate in the study
32
1st name | |
Middle name | |
Last name | TAKEDA Takayuki |
Uji-Tokushukai Medical Center
Department of Respiratory Medicine
86, Kasugamori, Ogura-cho, Uji-city, Kyoto
0774-20-1111
dyckw344@yahoo.co.jp
1st name | |
Middle name | |
Last name | TAKEDA Takayuki |
Uji-Tokushukai Medical Center
Department of Respiratory Medicine
86, Kasugamori, Ogura-cho, Uji-city, Kyoto
0774-20-1111
dyckw344@yahoo.co.jp
Tokushukai Group Oncology Project
Uji-Tokushukai Medical Center
Self funding
NO
宇治徳洲会病院、札幌東徳洲会病院、千葉徳洲会病院、湘南鎌倉総合病院、湘南藤沢徳洲会病院、八尾徳洲会病院、大隅鹿屋病院
2013 | Year | 06 | Month | 18 | Day |
Unpublished
Completed
2013 | Year | 06 | Month | 10 | Day |
2013 | Year | 07 | Month | 08 | Day |
2016 | Year | 07 | Month | 08 | Day |
2016 | Year | 07 | Month | 08 | Day |
2016 | Year | 07 | Month | 08 | Day |
2016 | Year | 07 | Month | 08 | Day |
2013 | Year | 06 | Month | 18 | Day |
2018 | Year | 12 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012863