April. 27, 2020 |
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Dec. 13, 2023 |
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jRCT1031200023 |
JCOG1901: An intergroup phase III study of combination therapy with everolimus and lanreotide versus everolimus monotherapy for unresectable or recurrent gastroenteropancreatic neuroendocrine tumor (STARTER-NET) |
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JCOG1901: An intergroup phase III study of combination therapy with everolimus and lanreotide versus everolimus monotherapy for unresectable or recurrent gastroenteropancreatic neuroendocrine tumor (STARTER-NET) |
MIZUNO Nobumasa |
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Aichi Cancer Center Hospital |
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1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan |
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+81-52-762-6111 |
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nobumasa@aichi-cc.jp |
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MIZUNO Nobumasa |
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Aichi Cancer Center Hospital |
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1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan |
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+81-52-762-6111 |
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nobumasa@aichi-cc.jp |
Recruiting |
April. 27, 2020 |
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May. 18, 2020 | ||
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) Histologically proven well-differentiated neuroendocrine tumor. |
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(1) History of synchronous or metachronous (within 2 years) malignancies with 5-year relative survivals of less than 95% at the time of diagnosis.) |
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20age old over | ||
No limit | ||
Both |
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Unresectable or reccurent gastroenteropancreatic neuroendocrine tumor. |
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Arm A : Daily oral administration of everolimus (10mg/body), until meeting the termination criteria for protocol treatment. |
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progression free survival |
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Overall survival (key secondary), response rate, disease control rate, adverse event rate. |
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 | |
Feb. 27, 2020 |
none |