Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected Stage IIIB/IV Gastric Cancer

A Randomized, Multicenter, Open-label, Phase III Trial of Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected (D2) Gastric Cancer of Stage IIIB/IV (M0)

Docetaxel was the first drug that showed survival benefits when added to the CF regimen, but it was very toxic. Docetaxel is also has a synergistic anti-cancer effect with S-1, in phase I/II studies. The use of a docetaxel plus S-1 combination as first-line chemotherapy for advanced gastric cancer achieved response rates of 46~56% and a median survival time of 14.0~14.3 months.

Based upon this background, the aim of this study is to detect a significant increase in 3 year DFS of disease for the test group (DS) relative to the Control group (SP).

Inclusion Criteria:

• Histologically proven, Stage IIIb/ IIIc curatively resected gastric carcinoma
• ECOG performance status 0-1
• Curatively resected advanced gastric cancer patients of stage IIIb/IIIc
• D2 lymph node dissection with R0 surgery
• Signed informed consent

Exclusion Criteria:

• Subjects with documented distant metastasis.
• Malabsorption syndrome or disease significantly affecting gastrointestinal function
• Patients with other uncontrolled systemic illness, e.g. infection, poorly controlled HTN
• History of other malignancy. Subjects who have been disease-free for 5 years or subjects with successfully treated in situ carcinoma are eligible.
• Subjects with preoperative/adjuvant other cancer treatment, such as chemotherapy, immunotherapy and radiotherapy