Clinical Trial

. 2021 Feb 8;51(2):235-243.

doi: 10.1093/jjco/hyaa198.

Randomized phase II study of chemoradiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer: Japan Clinical Oncology Group trial, JCOG1106

Tatsuya Ioka^{1

2}, Junji Furuse³, Akira Fukutomi⁴, Junki Mizusawa⁵, Satoaki Nakamura⁶, Nobuyoshi Hiraoka⁷, Yoshinori Ito⁸, Hiroshi Katayama⁵, Makoto Ueno⁹, Masafumi Ikeda¹⁰, Kazuya Sugimori¹¹, Naohiro Okano³, Kyoko Shimizu¹², Hiroaki Yanagimoto¹³, Takuji Okusaka¹⁴, Masato Ozaka¹⁵, Akiko Todaka⁴, Shoji Nakamori¹⁶, Kazutoshi Tobimatsu¹⁷, Naohiro Sata¹⁸, Yohei Kawashima¹⁹, Ayumu Hosokawa²⁰, Taketo Yamaguchi²¹, Hiroyuki Miyakawa²², Hiroki Hara²³, Nobumasa Mizuno²⁴, Hiroshi Ishii²⁵; Hepatobiliary and Pancreatic Oncology Group (HBPOG) of Japan Clinical Oncology Group (JCOG)

Affiliations

¹ Department of Cancer Survey and Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka.
² Department of Oncology Center, Yamaguchi University Hospital, Yamaguchi, Japan.
³ Department of Medical Oncology, Kyorin University Faculty of Medicine, Mitaka.
⁴ Divison of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka.
⁵ Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo.
⁶ Division of Radiation Oncology, Kansai Medical University Hospital, Osaka.
⁷ Division of Pathology and Clinical Laboratories, National Cancer Center Hospital, Tokyo.
⁸ Department of Radiation Oncology, National Cancer Center Hospital, Tokyo.
⁹ Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Yokohama.
¹⁰ Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa.
¹¹ Gastroenterological Center, Yokohama City University Medical Center, Yokohama.
¹² Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo.
¹³ Department of Surgery, Kansai Medical University, Osaka.
¹⁴ Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo.
¹⁵ Department of Gastroenterology, Cancer Institute Hospital, Tokyo.
¹⁶ Department of Hepatobiliary and Pancreatic Surgery, Osaka National Hospital, Osaka.
¹⁷ Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe.
¹⁸ Department of Surgery, Jichi Medical University School of Medicine, Shimotsuke.
¹⁹ Department of Gastroenterology, Tokai University School of Medicine, Isehara.
²⁰ Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama.
²¹ Department of Gastroenterology, Chiba Cancer Center, Chiba, Japan.
²² Division of Biliopancreatology, Sapporo Kosei General Hospital, Sapporo.
²³ Department of Gastroenterology, Saitama Cancer Center, Saitama.
²⁴ Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya.
²⁵ Clinical Research Center, Chiba Cancer Center, Chiba.

PMID: 33164066
DOI: 10.1093/jjco/hyaa198

Clinical Trial

Randomized phase II study of chemoradiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer: Japan Clinical Oncology Group trial, JCOG1106

Tatsuya Ioka et al. Jpn J Clin Oncol. 2021.

. 2021 Feb 8;51(2):235-243.

doi: 10.1093/jjco/hyaa198.

Authors

Affiliations

¹ Department of Cancer Survey and Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka.
² Department of Oncology Center, Yamaguchi University Hospital, Yamaguchi, Japan.
³ Department of Medical Oncology, Kyorin University Faculty of Medicine, Mitaka.
⁴ Divison of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka.
⁵ Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo.
⁶ Division of Radiation Oncology, Kansai Medical University Hospital, Osaka.
⁷ Division of Pathology and Clinical Laboratories, National Cancer Center Hospital, Tokyo.
⁸ Department of Radiation Oncology, National Cancer Center Hospital, Tokyo.
⁹ Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Yokohama.
¹⁰ Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa.
¹¹ Gastroenterological Center, Yokohama City University Medical Center, Yokohama.
¹² Institute of Gastroenterology, Tokyo Women's Medical University, Tokyo.
¹³ Department of Surgery, Kansai Medical University, Osaka.
¹⁴ Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo.
¹⁵ Department of Gastroenterology, Cancer Institute Hospital, Tokyo.
¹⁶ Department of Hepatobiliary and Pancreatic Surgery, Osaka National Hospital, Osaka.
¹⁷ Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe.
¹⁸ Department of Surgery, Jichi Medical University School of Medicine, Shimotsuke.
¹⁹ Department of Gastroenterology, Tokai University School of Medicine, Isehara.
²⁰ Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama.
²¹ Department of Gastroenterology, Chiba Cancer Center, Chiba, Japan.
²² Division of Biliopancreatology, Sapporo Kosei General Hospital, Sapporo.
²³ Department of Gastroenterology, Saitama Cancer Center, Saitama.
²⁴ Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya.
²⁵ Clinical Research Center, Chiba Cancer Center, Chiba.

PMID: 33164066
DOI: 10.1093/jjco/hyaa198

Abstract

Background: Chemoradiotherapy is a treatment option for locally advanced pancreatic cancer. However, the efficacy of induction chemotherapy prior to chemoradiotherapy is uncertain. The aim of this randomized, multicentre phase II study is to evaluate the efficacy and safety of chemoradiotherapy with and without induction chemotherapy to determine the significance of induction chemotherapy.

Methods: Patients with locally advanced pancreatic cancer were randomly assigned to the chemoradiotherapy arm (Arm A) or induction chemotherapy followed by the chemoradiotherapy arm (Arm B). Patients in Arm A underwent radiotherapy with concurrent S-1. Patients in Arm B received induction gemcitabine for 12 weeks, and thereafter, only patients with controlled disease underwent the same chemoradiotherapy as Arm A. After chemoradiotherapy, gemcitabine was continued until disease progression or unacceptable toxicity in both arms. The primary endpoint was overall survival.

Results: Amongst 102 patients enrolled, 100 were eligible for efficacy assessment. The probability of survival was greater in Arm B in the first 12 months, but the trend was reversed in the following periods (1-year survival 66.7 vs. 69.3%, 2-year survival 36.9 vs. 18.9%). The hazard ratio was 1.255 (95% confidence interval 0.816-1.930) in favour of Arm A. Gastrointestinal toxicity was slightly more frequent and three treatment-related deaths occurred in Arm A.

Conclusions: This study suggested that the chemoradiotherapy using S-1 alone had more promising efficacy with longer-term survival, compared with induction gemcitabine followed by chemoradiotherapy for locally advanced pancreatic cancer.

Clinical trial registration: The study was registered at the UMIN Clinical Trials Registry as UMIN000006811.

Keywords: S-1; chemoradiotherapy; gemcitabine; induction chemotherapy; pancreatic cancer.

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Randomized phase II study of chemoradiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer: Japan Clinical Oncology Group trial, JCOG1106

Affiliations

Randomized phase II study of chemoradiotherapy with versus without induction chemotherapy for locally advanced pancreatic cancer: Japan Clinical Oncology Group trial, JCOG1106

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