Jan. 30, 2019 |
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April. 24, 2023 |
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jRCTs051180042 |
Phase 2 study of gemcitabine and docetaxel chemotherapy for advanced bone and soft tissue sarcomas (GD therapy for advanced sarcomas) |
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GD therapy for advanced sarcomas (GD therapy for advanced sarcomas) |
Hara Hitomi |
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Kobe University Hospital |
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7-5-2, Kusunoki-cho, Chuo-ku, Kobe city |
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+81-78-382-5985 |
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mitohi@med.kobe-u.ac.jp |
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Hara Hitomi |
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Kobe University Hospital |
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7-5-2, Kusunoki-cho, Chuo-ku, Kobe city |
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+81-78-382-5985 |
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mitohi@med.kobe-u.ac.jp |
Recruiting |
Mar. 20, 2018 |
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Mar. 12, 2019 | ||
20 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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1)Patients are histopathologically diagnosed as the primary malignant tumor (sarcoma) of bone and soft tissue. |
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1)Active double cancers within 5 years(cured intraepithelial carcinoma and intramucosal carcinoma are not included) |
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10age 0month 0week old over | ||
70age 11month 4week old under | ||
Both |
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advanced pretreated bone and soft tissue sarcomas |
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Gemcitabine (900 mg/m2) intravenously(IV) on Day 1 and Day 8, and docetaxel (70 mg/m2) IV on Day 8, repeated every 3 weeks until progression disease. |
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progression free survival |
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objective response rate, disease control rate, incidence rate of adverse event, overall survival |
Kobe University Clinical Research Ethical Committee | |
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo | |
+81-78-382-6669 |
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cerb@med.kobe-u.ac.jp | |
Approval | |
No |
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UMIN000031004 | |
UMIN Clinical Trials Registry (UMIN-CTR) |
none |