July. 14, 2023 |
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Aug. 09, 2024 |
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jRCTs031230231 |
JCOG2204: A randomized phase II study to compare the pathological responses of neoadjuvant chemotherapy for type 4 or large type 3 gastric cancer: 5-FU, Oxaliplatin and Docetaxel (FLOT) versus Docetaxel, Oxaliplatin and S-1 (DOS) (SCIRRHOUS FLOT/DOS) |
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JCOG2204: A randomized phase II study to compare the pathological responses of neoadjuvant chemotherapy for type 4 or large type 3 gastric cancer: 5-FU, Oxaliplatin and Docetaxel (FLOT) versus Docetaxel, Oxaliplatin and S-1 (DOS) (SCIRRHOUS FLOT/DOS) |
OHASHI Manabu |
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The Cancer Institute Hospital of Japanese Foundation for Cancer Research |
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3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. |
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+81-3-3520-0111 |
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manabu.ohashi@jfcr.or.jp |
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MAKUUCHI Rie |
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The Cancer Institute Hospital of Japanese Foundation for Cancer Research |
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3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. |
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+81-3-3520-0111 |
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rie.makuuchi@jfcr.or.jp |
Recruiting |
July. 14, 2023 |
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July. 31, 2023 | ||
76 | ||
Interventional |
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randomized controlled trial |
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open(masking not used) |
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active control |
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parallel assignment |
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treatment purpose |
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(1) Pathologically proven adenocarcinoma with endoscopic biopsy specimen. |
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(1) Synchronous or metachronous (within 5 years) malignancies except for cancer with a 5-year relative survival rate of >= 95%, such as carcinoma in situ, intramucosal tumor, or early-stage cancers. |
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18age old over | ||
79age old under | ||
Both |
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Resectable large type 3 or type 4 gastric cancer |
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Arm A: Preoperative chemotherapy with 5-FU, Levofolinate, Oxaliplatin, and Docetaxel (FLOT) followed by surgery with lymph node dissection and postoperative chemotherapy with S-1 or Docetaxel plus S-1 (DS) for one year |
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A proportion of patients with pathological response >= Grade 1b according to the 15th edition of the Japanese Classification of Gastric Carcinoma (independent central pathological review) |
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a proportion of pathological response >= Grade 1b (assessed through an in-house pathological review), adverse events, a proportion of protocol treatment completion, response rate of neoadjuvant chemotherapy according to RECIST ver1.1, pre-and postoperative chemotherapy dose intensity, a proportion of R0 resection, a proportion of major pathological response (MPR), a proportion of patients undergoing postoperative chemotherapy at 3, 6, 9, and 12 months after surgery, progression-free survival, and overall survival |
National Cancer Center Japan | |
Not applicable |
National Cancer Center Hospital Certified Review Board | |
5-1-1 Tsukiji, Chuo-ku, Tokyo | |
+81-3-3542-2511 |
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ncch-irb@ml.res.ncc.go.jp | |
Approval | |
June. 02, 2023 |
none |