Phase II: To Assess the Pathologic CR Rate and Feasibility Following Neoadjuvant Chemoradiation Therapy With S1/Oxaliplatin, Phase I: To Determine the Maximum Tolerated Dose (MTD)
Conditions
Brief summary
To evaluate the efficacy of preoperative S-1/oxaliplatin/RT in locally advanced gastric cancer
Interventions
DRUGOxaliplatin, S-1, radiotherapy
Radiotherapy 4000cGy/20 fractions S-1 ( )mg/m2 po bid daily during radiotherapy Oxaliplatin at four dose levels (\_\_\_mg/m2 iv weekly x 4 weeks)
Sponsors
Samsung Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years * Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma ③ Localized gastric cancer of clinical stage (T2N(+), T3/T4) * ECOG performance status of 0 to 1 ⑤ Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 50mL/min ⑥ Written informed consent form
Exclusion criteria
* T1 (regardless of N stage), T2N0 * M1 ③ Peritoneal seeding ④ Uncontrolled medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD/pathologic CR | at the time of surgery |
Countries
South Korea
Outcome results
None listed