Unique ID issued by UMIN | C000000120 |
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Receipt number | R000000178 |
Scientific Title | Randomized phase II study of irinotecan and cisplatin or irinotecan, cisplatin and etoposide in patients with extensive small-cell lung cancer |
Date of disclosure of the study information | 2006/06/01 |
Last modified on | 2008/03/12 10:43:39 |
Randomized phase II study of irinotecan and cisplatin or irinotecan, cisplatin and etoposide in patients with extensive small-cell lung cancer
Randomized phase II study of IP vs IPE for E-SCLC
Randomized phase II study of irinotecan and cisplatin or irinotecan, cisplatin and etoposide in patients with extensive small-cell lung cancer
Randomized phase II study of IP vs IPE for E-SCLC
Japan |
Extensive small-cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To evaluate efficacy and safety of irinotecan and cisplatin therapy and irinotecan, cisplatin and etoposide therapy for extensive small-cell lung cancer
Safety,Efficacy
Exploratory
Explanatory
Phase II
median survival time
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Cisplatin 60 mg/m2 day 1 and irinotecan 60 mg/m2 days 1 and 8 were administered every 3 weeks for four cycles.
Cisplatin 60 mg/m2 day 1, irinotecan 60 mg/m2 days 1 and 8 and etoposide 50 mg/m2 days 1-3 were administered every 3 weeks for four cycles with prophylactic granulocyte colony-stimulating factor support.
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1) a histological or cytological diagnosis of SCLC; 2) no prior treatment; 3) measurable disease; 4) extensive disease, defined as having distant metastasis or contralateral hilar lymph node metastasis; 5) performance status of 0 to 2; 6) predicted life expectancy of 3 months; 7) adequate organ function as documented by a WBC count 4,000/micro L, neutrophil count 2,000/ micro L, hemoglobin 9.5 g/dl, platelet count 100,000/ micro L, total serum bilirubin 1.5 mg/dl, hepatic transaminases 100 IU/l, serum creatinine 1.2 mg/dl, creatinine clearance 60 ml/min, and PaO2 60 Torr; and 8) written informed consent.
1) uncontrollable pleural, pericardial effusion or ascites; 2) symptomatic brain metastasis; 3) active infection;4) contraindications for the use of irinotecan, including diarrhea, ileus, interstitial pneumonitis and lung fibrosis; 5) synchronous active malignancies; 6) serious concomitant medical illness, including severe heart disease, uncontrollable diabetes mellitus or hypertension; or 7) pregnancy or breast feeding.
110
1st name | |
Middle name | |
Last name | Tomohide Tamura |
National Cancer Center Hospital
Division of Medical Oncology
Tsukiji 5-1-1, Chuo-ku, Tokyo
03-3542-2511
1st name | |
Middle name | |
Last name | Ikuo Sekine |
Lung Cancer Study Group
Division of Medical Oncology, National Cancer Center Hospital
Tsukiji 5-1-1, Chuo-ku, Tokyo
03-3542-2511
isekine@ncc.go.jp
Division of Medical Oncology, National Cancer Center Hospital
Division of Policy-Based Medical Service Planning, National Cancer Center
Japan
NO
2006 | Year | 06 | Month | 01 | Day |
Published
Completed
2002 | Year | 02 | Month | 27 | Day |
2002 | Year | 03 | Month | 01 | Day |
2006 | Year | 12 | Month | 01 | Day |
2006 | Year | 12 | Month | 01 | Day |
2006 | Year | 12 | Month | 01 | Day |
2006 | Year | 12 | Month | 01 | Day |
2005 | Year | 09 | Month | 06 | Day |
2008 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000178
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