A Phase II study of systemic chemotherapy with docetaxel, cisplatin, and S-1 (DCS) followed by surgery in gastric cancer patients with extensive lymph node metastasis: Japan Clinical Oncology Group study JCOG1002

A Phase II trial was initiated in Japan to evaluate the efficacy and safety of preoperative chemotherapy with docetaxel, cisplatin and S-1 for gastric cancer with extensive lymph node metastasis. Patients are eligible to participate in the study if they have para-aortic lymph node metastases (statio...

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Bibliographic Details
Published in:Japanese journal of clinical oncology 2012-06, Vol.42 (6), p.556-559
Main Authors: Katayama, Hiroshi, Ito, Seiji, Sano, Takeshi, Takahari, Daisuke, Mizusawa, Junki, Boku, Narikazu, Tsuburaya, Akira, Terashima, Masanori, Sasako, Mitsuru
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Aorta
Chemotherapy, Adjuvant
Cisplatin - administration & dosage
Drug Combinations
Female
Gastrectomy - methods
Humans
Lymph Nodes - pathology
Lymphatic Metastasis
Male
Middle Aged
Oxonic Acid - administration & dosage
Stomach Neoplasms - drug therapy
Stomach Neoplasms - pathology
Stomach Neoplasms - surgery
Survival Analysis
Taxoids - administration & dosage
Tegafur - administration & dosage
Treatment Outcome
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Summary:A Phase II trial was initiated in Japan to evaluate the efficacy and safety of preoperative chemotherapy with docetaxel, cisplatin and S-1 for gastric cancer with extensive lymph node metastasis. Patients are eligible to participate in the study if they have para-aortic lymph node metastases (stations no. 16a2/16b1) and/or a bulky lymph node (≥3 cm × 1 or ≥1.5 cm × 2) along the celiac, splenic, common or proper hepatic arteries or the superior mesenteric vein, while patients with other distant metastases are ineligible. A total of 50 patients will be enrolled over 2.5 years. The primary endpoint is the response rate of the preoperative chemotherapy, which will be assessed based on the Response Evaluation Criteria in Solid Tumors ver. 1.0. The secondary endpoints are %3-year survival, %5-year survival, proportion of patients with R0 resection, proportion of patients who complete the preoperative chemotherapy and surgery, proportion of patients who complete the protocol treatment, pathological response rate and adverse events. This trial was registered at the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) as UMIN000006069.
ISSN:0368-2811
1465-3621
DOI:10.1093/jjco/hys054