Intraperitoneal Chemotherapy as Adjuvant or Perioperative Chemotherapy for Patients with Type 4 Scirrhous Gastric Cancer: PHOENIX-GC2 Trial
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 gas...
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MDPI AG
2021-11-01
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| Series: | Journal of Clinical Medicine |
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| Online Access: | https://www.mdpi.com/2077-0383/10/23/5666 |
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| author | Hironori Ishigami Yasushi Tsuji Hisashi Shinohara Yasuhiro Kodera Mitsuro Kanda Hiroshi Yabusaki Seiji Ito Motohiro Imano Hiroharu Yamashita Akio Hidemura Hironori Yamaguchi Takeo Fukagawa Koji Oba Joji Kitayama Yasuyuki Seto |
| author_facet | Hironori Ishigami Yasushi Tsuji Hisashi Shinohara Yasuhiro Kodera Mitsuro Kanda Hiroshi Yabusaki Seiji Ito Motohiro Imano Hiroharu Yamashita Akio Hidemura Hironori Yamaguchi Takeo Fukagawa Koji Oba Joji Kitayama Yasuyuki Seto |
| author_sort | Hironori Ishigami |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T04:51:14Z |
| format | Article |
| id | doaj.art-4b1b3aa6962441909e342d96e8a8e915 |
| institution | Directory Open Access Journal |
| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-10T04:51:14Z |
| publishDate | 2021-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Clinical Medicine |
| spelling | doaj.art-4b1b3aa6962441909e342d96e8a8e9152023-11-23T02:37:32ZengMDPI AGJournal of Clinical Medicine2077-03832021-11-011023566610.3390/jcm10235666Intraperitoneal Chemotherapy as Adjuvant or Perioperative Chemotherapy for Patients with Type 4 Scirrhous Gastric Cancer: PHOENIX-GC2 TrialHironori Ishigami0Yasushi Tsuji1Hisashi Shinohara2Yasuhiro Kodera3Mitsuro Kanda4Hiroshi Yabusaki5Seiji Ito6Motohiro Imano7Hiroharu Yamashita8Akio Hidemura9Hironori Yamaguchi10Takeo Fukagawa11Koji Oba12Joji Kitayama13Yasuyuki Seto14Department of Chemotherapy, The University of Tokyo Hospital, Tokyo 113-8655, JapanDepartment of Medical Oncology, Tonan Hospital, Sapporo 060-0004, JapanDepartment of Gastroenterological Surgery, Division of Upper GI, Hyogo College of Medicine, Nishinomiya 663-8507, JapanDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya 466-8550, JapanDepartment of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, Nagoya 466-8550, JapanDepartment of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata 951-8566, JapanDepartment of Gastrointestinal Surgery, Aichi Cancer Center Hospital, Nagoya 464-8681, JapanDepartment of Surgery, Kindai University Faculty of Medicine, Osakasayama 589-8511, JapanDepartment of Digestive Surgery, Nihon University School of Medicine, Tokyo 101-8309, JapanDepartment of Surgery, Kanto Rosai Hospital, Kawasaki 211-8510, JapanDepartment of Clinical Oncology, Jichi Medical University Hospital, Shimotsuke 329-0498, JapanDepartment of Surgery, Teikyo University School of Medicine, Tokyo 173-8605, JapanInterfaculty Initiative in Information Studies, Department of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo 113-0033, JapanClinical Research Center, Department of Surgery, Jichi Medical University, Shimotsuke 329-0498, JapanDepartment of Gastrointestinal Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo 113-8655, JapanThe 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.https://www.mdpi.com/2077-0383/10/23/5666type 4 gastric cancerperitoneal metastasisadjuvant chemotherapyperioperative chemotherapyintraperitoneal chemotherapyrandomized clinical trial |
| spellingShingle | Hironori Ishigami Yasushi Tsuji Hisashi Shinohara Yasuhiro Kodera Mitsuro Kanda Hiroshi Yabusaki Seiji Ito Motohiro Imano Hiroharu Yamashita Akio Hidemura Hironori Yamaguchi Takeo Fukagawa Koji Oba Joji Kitayama Yasuyuki Seto Intraperitoneal Chemotherapy as Adjuvant or Perioperative Chemotherapy for Patients with Type 4 Scirrhous Gastric Cancer: PHOENIX-GC2 Trial Journal of Clinical Medicine type 4 gastric cancer peritoneal metastasis adjuvant chemotherapy perioperative chemotherapy intraperitoneal chemotherapy randomized clinical trial |
| title | Intraperitoneal Chemotherapy as Adjuvant or Perioperative Chemotherapy for Patients with Type 4 Scirrhous Gastric Cancer: PHOENIX-GC2 Trial |
| title_full | Intraperitoneal Chemotherapy as Adjuvant or Perioperative Chemotherapy for Patients with Type 4 Scirrhous Gastric Cancer: PHOENIX-GC2 Trial |
| title_fullStr | Intraperitoneal Chemotherapy as Adjuvant or Perioperative Chemotherapy for Patients with Type 4 Scirrhous Gastric Cancer: PHOENIX-GC2 Trial |
| title_full_unstemmed | Intraperitoneal Chemotherapy as Adjuvant or Perioperative Chemotherapy for Patients with Type 4 Scirrhous Gastric Cancer: PHOENIX-GC2 Trial |
| title_short | Intraperitoneal Chemotherapy as Adjuvant or Perioperative Chemotherapy for Patients with Type 4 Scirrhous Gastric Cancer: PHOENIX-GC2 Trial |
| title_sort | intraperitoneal chemotherapy as adjuvant or perioperative chemotherapy for patients with type 4 scirrhous gastric cancer phoenix gc2 trial |
| topic | type 4 gastric cancer peritoneal metastasis adjuvant chemotherapy perioperative chemotherapy intraperitoneal chemotherapy randomized clinical trial |
| url | https://www.mdpi.com/2077-0383/10/23/5666 |
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