June. 03, 2019 |
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July. 31, 2024 |
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jRCT1031190035 |
JCOG1703: A multicenter randomized phase III study for newly-diagnosed maximally resected glioblastoma comparing Carmustine wafer implantation followed by chemoradiotherapy with temozolomide with chemoradiotherapy alone (MACS) |
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JCOG1703: A multicenter randomized phase III study for newly-diagnosed maximally resected glioblastoma comparing Carmustine wafer implantation followed by chemoradiotherapy with temozolomide with chemoradiotherapy alone (MACS) |
KUMABE Toshihiro |
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Kitasato University Hospital |
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1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa |
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+81-42-778-8111 |
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kuma@kitasato-u.ac.jp |
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KUMABE Toshihiro |
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Kitasato University Hospital |
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1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa |
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+81-42-778-8111 |
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kuma@kitasato-u.ac.jp |
Not Recruiting |
June. 03, 2019 |
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June. 19, 2019 | ||
250 | ||
Interventional |
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randomized controlled trial |
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open(masking not used) |
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active control |
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parallel assignment |
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treatment purpose |
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(1) Suspicious as the primary glioblastoma on preoperative head contrast MRI. |
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(1) Synchronous or metachronous (within 2 years) malignancies |
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20age old over | ||
75age old under | ||
Both |
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glioblastoma |
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Arm A: |
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Overall survival |
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Progression-free survival, Loco-regional progression-free survival, Proportion of adverse events |
National Cancer Center Japan | |
Not applicable |
Japan Agency for Medical Research and Development | |
Not applicable |
National Cancer Center Hospital Certified Review Board | |
5-1-1 Tsukiji, Chuo-ku, Tokyo | |
+81-3-3542-2511 |
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ncch-irb@ml.res.ncc.go.jp | |
Approval | |
April. 03, 2019 |
No |
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none |