2024-03-28T10:13:12Z
https://nagoya.repo.nii.ac.jp/oai
oai:nagoya.repo.nii.ac.jp:00028241
2023-11-16T02:57:33Z
499:508:509:2418
Phase II study of chemoradiotherapy combined with gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic ductal adenocarcinoma (NUPAT 05 Trial): study protocol for a single arm phase II study
Takano, Nao
92029
Yamada, Suguru
92030
Hirakawa, Akihiro
92031
Yokoyama, Yukihiro
92032
Kawashima, Hiroki
92033
Maeda, Osamu
92034
Okada, Tohru
92035
Ohno, Eizaburo
92036
Yamaguchi, Junpei
92037
Ishikawa, Takuya
92038
Sonohara, Fuminori
92039
Suenaga, Masaya
92040
Takami, Hideki
92041
Hayashi, Masamichi
92042
Niwa, Yukiko
92043
Hirooka, Yoshiki
92044
Ito, Yoshiyuki
92045
Naganawa, Shinji
92046
Ando, Yuichi
92047
Nagino, Masato
92048
Goto, Hidemi
92049
Fujii, Tsutomu
92050
Kodera, Yasuhiro
92051
II study
Gemcitabine
nab-paclitaxel
chemoradiation
unresectable locally advanced pancreatic cancer
2019-05
The efficacy of nab-paclitaxel combined with gemcitabine (GnP) and of chemoradiotherapy (CRT) for unresectable locally advanced pancreatic ductal adenocarcinoma (UR-LA PDAC) is still unclear. We previously conducted a phase I study of CRT using GnP and determined the recommended dose and have now designed a phase II trial to evaluate the efficacy of CRT incorporating GnP for UR-LA PDAC. Eligibility criteria are chemotherapy-naïve patients with UR-LA PDAC as defined by the NCCN guidelines version 2. 2016. Study patients will receive 100 mg/m2 nab-paclitaxel and 800 mg/m2 gemcitabine on Days 1, 8, and 15 per 4-week cycle with concurrent radiation therapy (total dose of 50.4 Gy in 28 fractions of 1.8 Gy per day, 5 days per week). Treatment will be continued until disease progression or surgery, which is to be performed only for patients in whom the disease is well-controlled at 8 months from beginning the protocol treatment. Primary endpoint is 2-year overall survival rate and co-primary endpoint is resection rate. Secondary endpoints are overall survival, progression free survival, time to treatment failure, response rate, disease control rate, early tumor shrinkage, depth of response, reduction of SUV-max on PET–CT, serum tumor markers, relative dose intensity, safety, and Quality of life. This study will show the efficacy and safety of chemoradiotherapy combined with GnP.
departmental bulletin paper
Nagoya University Graduate School of Medicine, School of Medicine
2019-05
Nagoya Journal of Medical Science
2
81
233
239
2186-3326
0027-7622
eng
http://www.med.nagoya-u.ac.jp/medlib/nagoya_j_med_sci/812.html
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