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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.

Authors
  • Takano, Nao1
  • Yamada, Suguru1
  • Hirakawa, Akihiro2
  • Yokoyama, Yukihiro3
  • Kawashima, Hiroki4
  • Maeda, Osamu5
  • Okada, Tohru6
  • Ohno, Eizaburo4
  • Yamaguchi, Junpei3
  • Ishikawa, Takuya4
  • Sonohara, Fuminori1
  • Suenaga, Masaya1
  • Takami, Hideki1
  • Hayashi, Masamichi1
  • Niwa, Yukiko1
  • Hirooka, Yoshiki7
  • Ito, Yoshiyuki6
  • Naganawa, Shinji6
  • Ando, Yuichi5
  • Nagino, Masato3
  • And 3 more
  • 1 Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Nagoya, Japan. , (Japan)
  • 2 Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. , (Japan)
  • 3 Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan. , (Japan)
  • 4 Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan. , (Japan)
  • 5 Department of Clinical Oncology and Chemotherapy, Nagoya University Graduate School of Medicine, Nagoya, Japan. , (Japan)
  • 6 Department of Radiology, Nagoya University Graduate School of Medicine, Nagoya, Japan. , (Japan)
  • 7 Department of Endoscopy, Nagoya University Graduate School of Medicine, Nagoya, Japan. , (Japan)
  • 8 Department of Surgery and Science, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan. , (Japan)
Type
Published Article
Journal
Nagoya journal of medical science
Publication Date
May 01, 2019
Volume
81
Issue
2
Pages
233–239
Identifiers
DOI: 10.18999/nagjms.81.2.233
PMID: 31239592
Source
Medline
Keywords
Language
English
License
Unknown

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.

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