Study protocol of the HGCSG1803: a phase II multicentre, non-randomised, single-arm, prospective trial of combination chemotherapy with oxaliplatin, irinotecan and S-1 (OX-IRIS) as first-line treatment for metastatic or relapsed pancreatic cancer
Naoya Sakamoto,
Michio Nakamura,
Isao Yokota,
Yoshito Komatsu,
Yasuyuki Kawamoto,
Satoshi Yuki,
Yasuo Takahashi,
Yasushi Tsuji,
Atsushi Sato,
Shintaro Nakano,
Kazuaki Harada,
Takuto Miyagishima,
Susumu Sogabe,
Masayoshi Dazai,
Atsushi Ishiguro,
Shinya Kajiura,
Miki Tateyama,
Kazuteru Hatanaka,
Takahide Sasaki,
Yoshiaki Shindo,
Tomoe Kobayashi,
Yuh Sakata
Affiliations
Naoya Sakamoto
2 Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan
Michio Nakamura
Nephrology Center, Toranomon Hospital, Tokyo, Japan
Isao Yokota
13Hokkaido University, Department of Biostatistics, Sapporo, Japan
Yoshito Komatsu
Cancer Center, Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Yasuyuki Kawamoto
Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan
Satoshi Yuki
Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan
Yasuo Takahashi
8 Department of Gastroenterology, National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, Japan
Yasushi Tsuji
4 Department of of Medical Oncology, Tonan Hospital, Sapporo, Hokkaido, Japan
Atsushi Sato
6 Department of Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan
Shintaro Nakano
Department of Cardiology, Saitama Medical University International Medical Center, Hidaka, Japan
Kazuaki Harada
2 Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan
Takuto Miyagishima
3 Department of Medical Oncology, Kushiro Rosai Hospital, Kushiro, Japan
Susumu Sogabe
4 Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo, Japan
Masayoshi Dazai
5 Department of Gastroenterology, Sapporo Medical Center NTT EC, Sapporo, Japan
Atsushi Ishiguro
7 Department of Medical Oncology, Teine Keijinkai Hospital, Sapporo, Japan
Shinya Kajiura
9 Department of Gastroenterology and Hematology, Faculty of medicine, University of Toyama, Toyama, Japan
Miki Tateyama
11 Division of Internal Medicine, Tomakomai Nisshou Hospital, Sapporo, Japan
Kazuteru Hatanaka
12 Department of Gastroenterology, Hakodate Municipal Hospital, Hakodate, Japan
Takahide Sasaki
14 Department of Internal Medicine, Hokkaido Gastroenterology Hospital, Sapporo, Japan
Yoshiaki Shindo
15 Department of Gastroenterological Surgery, Nakadori General Hospital, Akita, Japan
Tomoe Kobayashi
16 Department of Gastroenterology, Tomakomai City Hospital, Tomakomai, Japan
Introduction Combination chemotherapy with oxaliplatin, irinotecan, fluorouracil and leucovorin (FOLFIRINOX) has become one of the standard treatments for metastatic pancreatic cancer. However, the use of FOLFIRINOX requires prolonged infusion. Therefore, we planned to develop a new combination chemotherapy regimen with oxaliplatin, irinotecan and S-1 (OX-IRIS) for advanced pancreatic cancer. In the phase Ⅰ study that was conducted previously, the safety and recommended dose of OX-IRIS were assessed. In this study, we will evaluate the efficacy and safety of OX-IRIS.Methods and analysis The HGCSG1803 study started as a multicentre, non-randomised, single-arm, prospective, phase II study in December 2019. Eligible subjects were patients with untreated metastatic or relapsed pancreatic cancer. OX-IRIS is administered as follows: 30 min infusion of antiemetic; 2-hour infusion of oxaliplatin (65 mg/m2); 1.5-hour infusion of irinotecan (100 mg/m2) on day 1 and 15 of each 4-week cycle; and oral S-1 (40 mg/m2) twice daily from after dinner on day one to after breakfast on day 15, followed by a 14-day rest, to be repeated every 2 weeks until disease progression, unacceptable toxicity or patient refusal. The primary endpoint is response rate. The secondary endpoints are overall and progression-free survival, safety and dose for each drug. Using a binomial test, a sample size of 40 patients was set with a threshold value of 10% and expected value of 30%. Registration of 40 cases is planned from 18 institutions in Japan.Ethics and dissemination All the procedures will be conducted in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Declaration of Helsinki of 1964 and its later versions. All the patients will receive written information about the trial and will provide informed consent before enrolment. This trial was approved by the Hokkaido University Certified Review Board (approval No: 018-037).Trial registration number jRCTs011190008.
