The primary objective of this trial is: * To determine whether it is feasible in locally advanced gastric or gastroesophageal cancer to administer 3 cycles of Docetaxel, Oxaliplatin and S-1 as a chemotherapy scheme and also to determine what toxicities are involved. The secondary objective of this trial are to describe: * The disease free survival at one and two years in that subgroup of patients that has undergone a R0 resection. * The downstaging after 3 cycles of chemotherapy, pCR in that subgroup of patients that have undergone an R0 resection and progression-free survival and overall survival at one and two years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
50 mg/m² IV as a 1 hour infusion on day 1 for each period of 3 weeks for 3 cycles.
80mg/m² day 1-14 every 3 weeks for 3 cycles. The curative resection group will receive two oral doses of 40 mg/m²/day for 4 weeks, followed by 2 weeks rest, for 1 year.
100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles.
Sanofi-Aventis Administrative Office
Seoul, South Korea
R0 resection rate
Time frame: At the end of the treatment period
Physical examination
Time frame: Every 3 months during the study period
Chest X-Ray
Time frame: Throughout the study period
Computed Tomography scan of the abdomen
Time frame: Every 6 months during the study period
Gastrofiberscopy
Time frame: Every 1 year from the completion of the treatment for 2 years
Laboratory analysis
Time frame: Throughout the study period
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