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

Nao Takano, Suguru Yamada, Akihiro Hirakawa, Yukihiro Yokoyama, Hiroki Kawashima, Osamu Maeda, Tohru Okada, Eizaburo Ohno, Junpei Yamaguchi, Takuya Ishikawa, Fuminori Sonohara, Masaya Suenaga, Hideki Takami, Masamichi Hayashi, Yukiko Niwa, Yoshiki Hirooka, Yoshiyuki Ito, Shinji Naganawa, Yuichi Ando, Masato NaginoHidemi Goto, Tsutomu Fujii, Yasuhiro Kodera

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Abstract

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.

Original languageEnglish
Pages (from-to)233-239
Number of pages7
JournalNagoya journal of medical science
Volume81
Issue number2
DOIs
Publication statusPublished - 01-05-2019

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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    Takano, N., Yamada, S., Hirakawa, A., Yokoyama, Y., Kawashima, H., Maeda, O., Okada, T., Ohno, E., Yamaguchi, J., Ishikawa, T., Sonohara, F., Suenaga, M., Takami, H., Hayashi, M., Niwa, Y., Hirooka, Y., Ito, Y., Naganawa, S., Ando, Y., ... Kodera, Y. (2019). 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. Nagoya journal of medical science, 81(2), 233-239. https://doi.org/10.18999/nagjms.81.2.233