The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin combined with radiation by Phase I/II study. The purpose of this study is as follows, * In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD). * In phase II, to evaluate the antitumor effect (pCR rate) and the safety .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
40mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week.
40-60mg/m2/week intravenously on day 1, 8, 22 and 29.
Total dose is 50.4Gy (1.8Gy X 28 fractions)
Nagoya University Graduate School of Medicine
Nagoya, Japan
Osaka Medical College
Osaka, Japan
Jichi Medical University Hospital
Tochigi, Japan
Tokyo University
Tokyo, Japan
Phase I: Determine the Recommended dose (RD)
Based on the incidence of dose-limited toxicities(DLT), the RD is determined from 4 test levels
Time frame: 10 weeks
Phase II: pathological complete response rate
Pathological complete response(pCR) rate is calculated by numbers of pCR cases (grade 3) devided the number of subjected cases.
Time frame: 12-16 week
R0 resection rate
Time frame: 12-16 weeks
down staging rate
Time frame: 12-16 weeks
local reccurence rate
Time frame: 3 years
desease free survuval
Time frame: 3 years
safety
Time frame: 16-20 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cancer Institute Hospital
Tokyo, Japan
Teikyo University
Tokyo, Japan