Efficacy of aspirin for stage III colorectal cancer: a randomized double-blind placebo-controlled trial (JCOG1503C, EPISODE-III trial)
Autor: | Taro Shibata, Yuya Sato, Tetsuya Hamaguchi, Dai Shida, Junki Mizusawa, Yukihide Kanemitsu, Kenichi Miyamoto, Atsuo Takashima, Hiroshi Katayama, Haruhiko Fukuda, Yasuhiro Shimada, Kenichi Nakamura |
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Rok vydání: | 2019 |
Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Placebo-controlled study Placebo Placebos 03 medical and health sciences 0302 clinical medicine Double-Blind Method Japan Internal medicine Clinical endpoint medicine Humans Radiology Nuclear Medicine and imaging 030212 general & internal medicine Stage (cooking) Adverse effect Aged Neoplasm Staging Aspirin business.industry Standard treatment General Medicine Middle Aged Clinical trial Treatment Outcome Oncology 030220 oncology & carcinogenesis Female Neoplasm Recurrence Local Colorectal Neoplasms business Follow-Up Studies medicine.drug |
Zdroj: | Japanese Journal of Clinical Oncology. 49:985-990 |
ISSN: | 1465-3621 |
Popis: | Adjuvant chemotherapy is the current standard treatment for stage III colorectal cancer after curative resection. However, the prognosis of stage III colorectal cancer is still poor even after curative resection and adjuvant chemotherapy. Several observational studies suggested that the anti-tumor effect of aspirin. Therefore, we planned a randomized double-blind placebo-controlled phase III trial, which commenced in Japan in March 2018, to confirm the superiority of aspirin over placebo added to adjuvant chemotherapy in terms of disease-free survival (DFS) for stage III colorectal cancer patients after curative resection. A total of 880 patients will be accrued from 20 Japanese institutions within 3 years. The primary endpoint is DFS and the secondary endpoints are overall survival, relapse-free survival, relative dose intensity, adverse events, and serious adverse events. This trial has been registered at Japan Registry of Clinical Trials as jRCTs031180009 (https://jrct.niph.go.jp/detail/589). |
Databáze: | OpenAIRE |
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