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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
1. S-1: 70 mg/m2 #2 bid PO, D1-14 2. Docetaxel 30 mg/m2 IVF (for 1 hr) D1 and D8 3. Cisplatin 30 mg/m2 IVF (for 2 hrs, without hydration) D1 and D8, repeated by 3 weeks.
1. 5-FU: 1,000 mg/m2 CI, D1-3 2. Docetaxel 60 mg/m2 IVF (for 1 hr) D1 followed by 3. 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
Severance Hospital
Seoul, South Korea
RECIST(Response Evaluation Criteria in Solid Tumors)
* safety : every cycle adverse event/serious adversr event evaluation from NCI-CTC(version 3.0) * efficacy : tumor response is assessed every 2 cycles (6weeks) -\> tumor response assessment(RECIST\<Response Evaluation Criteria in Solid Tumor\> 1.0 version use)
Time frame: written in the description part below
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