Combined intraperitoneal and systemic chemotherapy as adjuvant or perioperative chemotherapy for patients with type 4 scirrhous gastric cancer: PHOENIX-GC2 trial.

Authors

null

Hironori Ishigami

Department of Chemotherapy, The University of Tokyo, Tokyo, Japan;

Hironori Ishigami , Takeshi Omori , Yasushi Tsuji , Hisashi Shinohara , Hiroshi Yabusaki , Daisuke Kobayashi , Daisuke Takahari , Hiroaki Hata , Tetsuya Kusumoto , Mitsuro Kanda , Koji Oba , Joji Kitayama , Yasuyuki Seto

Organizations

Department of Chemotherapy, The University of Tokyo, Tokyo, Japan; , Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan; , Department of Medical Oncology, Tonan Hospital, Sapporo, Japan; , Department of Gastroenterological Surgery, Division of Upper GI, Hyogo College of Medicine, Nishinomiya, Japan; , Department of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan; , Department of Gastroenterological Surgery, Komaki City Hospital, Komaki, Japan; , Department of Gastrointestinal Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan; , Department of Surgery, National Hospital Organization Kyoto Medical Center, Kyoto, Japan; , Department of Gastroenterological Surgery and Clinical Research Institute Cancer Research Division, National Kyushu Medical Center, Fukuoka, Japan; , Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan; , Interfaculty Initiative in Information Studies; Department of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; , Center for Clinical Investigation, Jichi Medical University Hospital, Shimotsuke, Japan; , Department of Gastrointestinal Surgery, The University of Tokyo, Tokyo, Japan;

Research Funding

Other
The University of Tokyo Hospital, The UTokyo Foundation

Background: Despite recent progress in adjuvant and perioperative chemotherapy, the prognosis of patients with type 4 scirrhous gastric cancer remains poor due to a high risk of peritoneal metastasis. We have previously developed combination chemotherapy regimens of intraperitoneal (IP) paclitaxel (PTX) and systemic chemotherapy, and promising clinical efficacy was reported in gastric cancer with peritoneal metastasis. Herein, a multicenter, open-label, randomized, phase III study is proposed to verify the efficacy of IP PTX to prevent peritoneal recurrence. Methods: Gastric cancer patients with type 4 tumors and without apparent distant metastasis, including peritoneal metastasis, will be randomized for standard systemic chemotherapy or combined IP and systemic chemotherapy based on peritoneal lavage cytology findings. Those with negative peritoneal cytology will receive radical gastrectomy and adjuvant chemotherapy of S-1 plus docetaxel (control arm), or S-1 plus intravenous and IP PTX (experimental arm). Those with positive peritoneal cytology will receive three courses of S-1 plus oxaliplatin (control arm), or S-1 plus oxaliplatin and IP PTX (experimental arm). Subsequently, they undergo gastrectomy and receive postoperative chemotherapy of S-1 plus docetaxel (control arm), or S-1 plus intravenous and IP PTX (experimental arm). The primary endpoint is disease free survival after a 3-year follow-up period. Secondary endpoints are overall survival, survival without peritoneal metastasis, safety, completion rate, curative resection rate, and histological response of preoperative chemotherapy. A total of 300 patients are to be enrolled from 40 hospitals throughout Japan. Clinical trial information: jRCT2031200087.

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Abstract Details

Meeting

2023 ASCO Gastrointestinal Cancers Symposium

Session Type

Trials in Progress Poster Session

Session Title

Trials in Progress Poster Session A: Cancers of the Esophagus and Stomach and Other GI Cancers

Track

Esophageal and Gastric Cancer,Other GI Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

jRCT2031200087

Citation

J Clin Oncol 41, 2023 (suppl 4; abstr TPS477)

DOI

10.1200/JCO.2023.41.4_suppl.TPS477

Abstract #

TPS477

Poster Bd #

N12

Abstract Disclosures