Intraperitoneal Chemotherapy as Adjuvant or Perioperative Chemotherapy for Patients with Type 4 Scirrhous Gastric Cancer: PHOENIX-GC2 Trial

Autor:	Hironori Ishigami, Takeo Fukagawa, Hiroharu Yamashita, Mitsuro Kanda, Yasuyuki Seto, Yasushi Tsuji, Akio Hidemura, Hisashi Shinohara, Motohiro Imano, Joji Kitayama, Seiji Ito, Yasuhiro Kodera, Hironori Yamaguchi, Koji Oba, Hiroshi Yabusaki
Jazyk:	angličtina
Rok vydání:	2021
Předmět:	medicine.medical_specialty medicine.medical_treatment intraperitoneal chemotherapy Gastroenterology Article chemistry.chemical_compound Internal medicine medicine Clinical endpoint business.industry Cancer Combination chemotherapy General Medicine randomized clinical trial medicine.disease type 4 gastric cancer peritoneal metastasis adjuvant chemotherapy perioperative chemotherapy Oxaliplatin Paclitaxel chemistry Docetaxel Medicine Gastrectomy business Adjuvant medicine.drug
Zdroj:	Journal of Clinical Medicine; Volume 10; Issue 23; Pages: 5666 Journal of Clinical Medicine, Vol 10, Iss 5666, p 5666 (2021) Journal of Clinical Medicine
ISSN:	2077-0383
DOI:	10.3390/jcm10235666
Popis:	The prognosis of patients with type 4 scirrhous gastric cancer remains poor due to a high risk of peritoneal metastasis. We have previously developed combined chemotherapy regimens of intraperitoneal (IP) paclitaxel (PTX) and systemic chemotherapy, and promising clinical efficacy was reported in gastric cancer with peritoneal metastasis. Herein, a randomized, phase III study is proposed to verify the efficacy of IP PTX to prevent peritoneal recurrence. 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.
Databáze:	OpenAIRE
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