Number of patients planned The study adopted two parallel phase II studies, with the same P1 and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively. Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern, 26 patients were required per arm to achieve the desired statistical power. Finally, taking a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.

Treatment scheme

• Screening period: D-21 to D1 (treatment day)

• Preoperative screening includes EUS, laparoscopy (optional), EGD and abd-pelvic CT scan.

• Preoperative clinical staging is based on the guideline of Japanese Gastric Cancer Association (JGCA, 1998)

• Tumor response is assessed every 2 cycles (6 weeks)

• Treatment is repeated until,.

  • 4 cycles
  • progressive disease
  • unacceptable toxicity
  • patient's withdrawal

• Gastric surgery should be performed within 4~6 weeks of the last dose of chemotherapy

• Gastric surgery is for curative aim and should include ≥ D2 LN dissection.

• Patients who received R0 resection should receive at least 4-cycled adjuvant chemotherapy with 5-FU and cisplatin.

• Palliative chemotherapy should be indicated for inoperable progressive disease or who failed curative resection. 5-FU and oxaliplatin combination is recommended as first-line therapy.

• Follow up for survival is repeated every 3 months for 2 years

Study period Patient enroll period for 12 months., and follow-up duration for further 12 months., resulting total study period of 24 months

Inclusion Criteria:

• Histologically/cytologically confirmed gastric adenocarcinoma

• Age 18 to 70 years old

• ECOG performance Status 0~1

• Preoperative clinical staging by Japanese Gastric Cancer Association (JGCA): cT3N2 (IIIB), cT4N0-3 (IIIA~IV), M0, P0, H0, CY0

• No pretreatment (radiotherapy or chemotherapy) for gastric cancer

• Adequate organ function

  • Hb ≥ 9.0 g/dL
  • WBC ≥ 4,000/µL
  • ANC ≥ 2,000/µL (*ANC = Neutrophil segs ＋ Neutrophil bands)
  • Platelet ≥ 100 × 103/ µL
  • Total bilirubin: ≤ 1.5 × UNL
  • CCr ≥ 60 ml/min (by laboratory or Cockcroft-Gault Formula)
  • AST/ALT, ALP: ≤ 2.5 × UNL

• Written informed consent

Exclusion Criteria:

• Distant metastasis on diagnosis
• cT1-2
• Cancer of gastroesophageal junction (GEJ)
• Poor oral intake or absorption deficiency syndrome
• Gastric outlet obstruction, perforation or bleeding
• Medically uncontrollable chronic illness or infection
• Pregnant or lactating women, women of childbearing potential not employing adequate contraception
• History of clinically significant cardiac disease
• Past or concurrent history of neoplasm last < 5 year other than gastric cancer
• Prior gastrectomized patients
• Concomitant administration of any other experimental drug under investigation
• Peripheral neuropathy ≥ NCI-CTC grade 2