Gastric Cancer
Conditions
Keywords
Gastric cancer, Adjuvant chemotherapy, S1, Oxaliplatin, Survival
Brief summary
The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with locally advanced gastric cancer.
Detailed description
The study is a multi-central, controlled, randomized Phase III trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival (OS) and safety.
Interventions
8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1
DRUGS-1 only
16 cycles of adjuvant chemotherapy with S-1 only
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* sign written informed consent form * age ≥ 18 years, ≤69 years * ECOG status: 0\ 2 * pathologically confirmed gastric cancer at stage II or IIIA (AJCC 7th version) * negative peritoneal cytology * underwent curative distal gastrectomy with D2 lymph node dissection * no prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy * adequate organ function as defined below: Hematologic ANC ≥ 2\*109/L, Platelets ≥ 100\*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.
Exclusion criteria
* be enrolled in other clinical trials * underwent prior antitumor treatment * allergic reaction to S-1 or oxaliplatin * abnormal GI tract function * female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy * other situation to be judged not adaptive to the study by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | up to 5 years | To evaluate the 1-year, 3-year and 5-year overall survival of GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX |
| Incidence of Treatment-Emergent Adverse Events [Safety] | 1 year | The incidence of chemotherapy related adverse events in GC patients underwent post-operative chemotherapy of S-1 compared with post-operative SOX |
Countries
China
Outcome results
None listed