BMC Cancer (Jul 2023)

Triple modal treatment comprising with proton beam radiation, hyperthermia, and gemcitabine/nab-paclitaxel for locally advanced pancreatic cancer: a phase I/II study protocol (TT-LAP trial)

  • Osamu Shimomura,
  • Masato Endo,
  • Hirokazu Makishima,
  • Takeshi Yamada,
  • Shinji Hashimoto,
  • Haruko Numajiri,
  • Yoshihiro Miyazaki,
  • Manami Doi,
  • Kinji Furuya,
  • Kazuhiro Takahashi,
  • Toshikazu Moriwaki,
  • Naoyuki Hasegawa,
  • Yoshiyuki Yamamoto,
  • Yusuke Niisato,
  • Mariko Kobayashi,
  • Masashi Mizumoto,
  • Kei Nakai,
  • Takashi Saito,
  • Sodai Hoshiai,
  • Tsukasa Saida,
  • Bryan J. Mathis,
  • Kensaku Mori,
  • Takahito Nakajima,
  • Kiichiro Tsuchiya,
  • Hideyuki Sakurai,
  • Tatsuya Oda

DOI
https://doi.org/10.1186/s12885-023-11110-y
Journal volume & issue
Vol. 23, no. 1
pp. 1 – 9

Abstract

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Abstract Background Locally advanced pancreatic ductal adenocarcinoma (PDAC), accounting for about 30% of PDAC patients, is difficult to cure by radical resection or systemic chemotherapy alone. A multidisciplinary strategy is required and our TT-LAP trial aims to evaluate whether triple-modal treatment with proton beam therapy (PBT), hyperthermia, and gemcitabine plus nab-paclitaxel is a safe and synergistically effective treatment for patients with locally advanced PDAC. Methods This trial is an interventional, open-label, non-randomized, single-center, single-arm phase I/II clinical trial organized and sponsored by the University of Tsukuba. Eligible patients who are diagnosed with locally advanced pancreatic cancer, including both borderline resectable (BR) and unresectable locally advanced (UR-LA) patients, and selected according to the inclusion and exclusion criteria will receive triple-modal treatment consisting of chemotherapy, hyperthermia, and proton beam radiation. Treatment induction will include 2 cycles of chemotherapy (gemcitabine plus nab-paclitaxel), proton beam therapy, and 6 total sessions of hyperthermia therapy. The initial 5 patients will move to phase II after adverse events are verified by a monitoring committee and safety is ensured. The primary endpoint is 2-year survival rate while secondary endpoints include adverse event rate, treatment completion rate, response rate, progression-free survival, overall survival, resection rate, pathologic response rate, and R0 (no pathologic cancer remnants) rate. The target sample size is set at 30 cases. Discussion The TT-LAP trial is the first to evaluate the safety and effectiveness (phases1/2) of triple-modal treatment comprised of proton beam therapy, hyperthermia, and gemcitabine/nab-paclitaxel for locally advanced pancreatic cancer. Ethics and dissemination This protocol was approved by the Tsukuba University Clinical Research Review Board (reference number TCRB22-007). Results will be analyzed after study recruitment and follow-up are completed. Results will be presented at international meetings of interest in pancreatic cancer plus gastrointestinal, hepatobiliary, and pancreatic surgeries and published in peer-reviewed journals. Trial registration Japan Registry of Clinical Trials, jRCTs031220160. Registered 24 th June 2022, https://jrct.niph.go.jp/en-latest-detail/jRCTs031220160 .

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