Unique ID issued by UMIN | UMIN000001129 |
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Receipt number | R000001327 |
Scientific Title | Gemcitabine versus gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a prospective randomized phase II study of the Niigata Lung Cancer Treatment Group |
Date of disclosure of the study information | 2008/05/01 |
Last modified on | 2018/06/14 10:35:16 |
Gemcitabine versus gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a prospective randomized phase II study of the Niigata Lung Cancer Treatment Group
Gemcitabine versus gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a prospective randomized phase II study of the Niigata Lung Cancer Treatment Group
Gemcitabine versus gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a prospective randomized phase II study of the Niigata Lung Cancer Treatment Group
Gemcitabine versus gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a prospective randomized phase II study of the Niigata Lung Cancer Treatment Group
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
To evaluate the response rate of elderly non-small cell lung cancer with chemotherapy (CBDCA+GEM vs Gem)
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Response rate
Progression free survival,safety, toxicity, QOL
Interventional
Parallel
Randomized
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Patients in group A will receive an infusion of gemcitabine on days 1 and
8.
Patients in group B will receive an infusion of gemcitabine on days 1 and
8. They will also receive an infusion of carboplatin on day 8.
70 | years-old | <= |
Not applicable |
Male and Female
Patients enrolled in this trial had histologically or cytologically
confirmed stage IIIb or IV NSCLC. Patients with stage IIIb disease who were
not candidates for thoracic radiation and those with stage IV disease were
eligible, if they had not received previous chemotherapy, had measurable
disease, and had a life expectancy of at least 3 months. Additional entry criteria were age 75=< years, performance
status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, and
adequate bone marrow (leukocyte count > 4,000/mL, neutrophil count >
2,000/mL, hemoglobin concentration > 9.5g/dL, platelet count > 100,000
/mL), kidney (creatinine < 1.2 mg/dL), liver (aspartate aminotransferase
[AST] and alanine aminotransferase [ALT] < 100, total bilirubin < 2.0 mg/dL), and pulmonary (PaO2 > 60 torr)
functions.
Patients were excluded if they had any active concomitant malignancies,
symptomatic brain metastases, past history of severe allergic reactions to drugs,
interstitial pneumonia identified by chest X-ray, superior vena cava syndrome, or other serious complications, such as uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure,
uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural
effusion or ascites.
60
1st name | |
Middle name | |
Last name | Hirohisa Yoshizawa |
Niigata University Medical and Dental Hospital
Bioscience Medical Research Center
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
025-227-2517
hy0522@med.niigata-u.ac.jp
1st name | |
Middle name | |
Last name | Hirohisa Yoshizawa |
Niigata University Medical and Dental Hospital
Bioscience Medical Research Center
1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
025-227-2517
hy0522@med.niigata-u.ac.jp
Niigata Lung Cancer Treatment Group
none
Self funding
NO
2008 | Year | 05 | Month | 01 | Day |
Unpublished
Terminated
2007 | Year | 10 | Month | 25 | Day |
2007 | Year | 11 | Month | 01 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 09 | Month | 30 | Day |
2008 | Year | 04 | Month | 24 | Day |
2018 | Year | 06 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001327
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