Protocol digest of randomized phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel combination therapy for locally advanced pancreatic cancer: Japan clinical oncology group study (JCOG1407) |
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| Authors: | Junki Mizusawa Akira Fukutomi Hiroshi Katayama Hiroshi Ishii Tatsuya Ioka Takuji Okusaka Hideki Ueno Makoto Ueno Masafumi Ikeda Nobumasa Mizuno Masato Ozaka Haruhiko Fukuda Junji Furuse |
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| Affiliation: | 1. JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan;2. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan;3. Clinical Research Center, National Hospital Organization Shikoku Cancer Center, Shizuoka, Japan;4. Department of Hepatobiliary and Pancreatic Oncology, Osaka International Cancer Institute, Japan;5. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Japan;6. Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Japan;g. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Japan;h. Department of Gastroenterology, Aichi Cancer Center Hospital, Japan;i. Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Japan;j. Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan |
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| Abstract: | Gemcitabine is one of the standard treatments for locally advanced pancreatic cancer. Recent studies on metastatic pancreatic cancer have shown that combination chemotherapy with oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) and gemcitabine plus nab-paclitaxel (GnP) prolonged the overall survival compared with gemcitabine alone. To select the most promising chemotherapy, a randomized phase II selection design trial was started in July 2016 to compare between modified FOLFIRINOX and GnP for patients with locally advanced pancreatic cancer. A total of 124 patients will be enrolled from 36 Japanese institutions within 2.5 years. The primary endpoint is the proportion of 1-year overall survival, and secondary endpoints are progression-free survival, distant metastasis-free survival, response rate in patients with target lesions, CA19-9 response, adverse events, treatment-related death, early death, grade 4 non-hematological toxicity, and dose intensity. This trial has been registered with the UMIN Clinical Trials Registry [http://www.umin.ac.jp/ctr/index.htm], and the registration number is UMIN000023143. |
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| Keywords: | Locally advanced pancreatic cancer Gemcitabine plus nab-paclitaxel FOLFIRINOX Phase II selection design |
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