June. 24, 2022 |
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Jan. 23, 2025 |
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jRCTs031220160 |
Safety and efficacy test of multimodality treatment combining proton beam therapy, hyperthermia, and gemcitabine-nab-paclitaxel therapy for locally advanced pancreatic cancer |
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Safety and efficacy of multimodality treatment for locally advanced PDAC (TT-LAP) |
Oda Tatsuya |
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University of Tsukuba Hospital |
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2-1-1 Amakubo,Tsukuba |
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+81-29-853-3221 |
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tatoda@md.tsukuba.ac.jp |
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Shimomura Osamu |
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University of Tsukuba Hospital |
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2-1-1 Amakubo,Tsukuba |
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+81-29-853-3221 |
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oshimomura@md.tsukuba.ac.jp |
Recruiting |
June. 24, 2022 |
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Sept. 16, 2022 | ||
30 | ||
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) Histological or cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC) |
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1) Patients with distant metastasis including paraaortic lumph node metastasis, peritoneal dissemination |
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20age old over | ||
80age old under | ||
Both |
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pancreatic cancer |
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Chemotherapy: |
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Phase 1 part: DLT rate |
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adverse event incident rate, treatment completion rate, response rate, progression free survival, overall survival, resection rate, pathological response rate, R0 resction rate, detection and analysis of circulating tumor cells (CTCs), radiation dose volume evaluation, molecular pathological findings of preoperative biopsy specimen and progonosis analysis, pathological analysis in resected patients after triple-modal treatment |
University of Tsukuba Hospital | |
Not applicable |
University of Tsukuba Clinical Research Review Board | |
Tennodai 1-1-1, Tsukuba, Ibaraki | |
+81-29-853-3749 |
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tcr.nintei@un.tsukuba.ac.jp | |
Approval | |
June. 15, 2022 |
No |
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none |