Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma
Condition: Gastric Cancer
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): DCS (docetaxel with cisplatin with TS-1); DCF (docetaxel with cisplatin with 5-FU)
Intervention type(s): Drug; Drug
Intervention description(s): S-1: 70 mg/m2 #2 bid PO, D1-14
Docetaxel 30 mg/m2 IVF (for 1 hr) D1 and D8
Cisplatin 30 mg/m2 IVF (for 2 hrs, without hydration) D1 and D8, repeated by 3 weeks.; 5-FU: 1,000 mg/m2 CI, D1-3
Docetaxel 60 mg/m2 IVF (for 1 hr) D1 followed by
Cisplatin 60 mg/m2 IVF (for 2 hrs, with hydration) D1, repeated by 3 weeks.
Intercycle or intracycle dose modification is indicated if ≥G3 hematologic toxicity (except anemia) or ≥G3 non-hematologic toxicity (except alopecia)
treatment is repeated until 4 cycles
Other intervention name(s): Taxotere; CDDP; TS-1; 5-FU; Taxotere; CDDP
Intervention MeSH terms: Cisplatin; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unresectable; locally advanced