Chemotherapy is an important therapeutic method for patients with advanced gastric cancer. However, there is currently no established standard chemotherapeutic regimen in the preoperative or neoadjuvant treatment setting. The aim of our study was to compare the efficacy and toxicity between SEEOX and SOX regimens. The investigators estimate that combined intravenous and intra-arterial intensified SEEOX preoperative chemotherapy may be a safe and promising regimen for locally advanced or initially unresectable gastric cancer patients.
Gastric cancer patients who will receive neoadjuvant chemotherapy would be included in this study. They would receive combined intravenous and intra-arterial intensified SEEOX neoadjuvant chemotherapy or SOX regimen at random. The efficacy and toxicity of these two regimens would be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
297
oxaliplatin 100 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group and SOX group. Intravenous oxaliplatin 130 mg/m2 was administered on day 1 of every cycle in SOX group.
etoposide 80 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.
pharmorubicin 30 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.
Jinling Hospital
Nanjing, Jiangsu, China
3 year progression free survival
time period calculated from randomization to the first disease progression, recurrence or death from any cause
Time frame: up to 7 years
Objective response rate
the proportion of patients with complete and partial response according to Response Evaluation Criteria in Solid Tumors guidelines (version 1.1)
Time frame: up to 4 years
R0 resection rate
the proportion of complete tumor resection with no microscopic or macroscopic residual diseases in all operations
Time frame: up to 4 years
3 year overall survival
time period calculated from randomization to death from any cause
Time frame: up to 7 years
Adverse events of preoperative chemotherapy
preoperative chemotherapy associated complications
Time frame: up to 4 years
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80\~120 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks in both SEEOX and SOX groups.