Oxaliplatin plus S-1: SOX group: eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (\<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; \>1.5m2 60mg twice a day, days 1 to 14 of each cycle).
Docetaxel plus S-1: DS group: S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year.
Study summary
This is a multicenter, open-label, phase 3, randomized, non-inferiority study aimed to investigate the effect on disease-free survival of adjuvant chemotherapy with oxaliplatin plus S-1 compared with adjuvant chemotherapy with docetaxel plus S-1 after D2 gastrectomy in patients with stage III gastric cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. age 18 to 80 years old, male and female
2. histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
3. patients underwent standard D2 gastrectomy and achieved R0 resection, and had no systemic therapy like neoadjuvant therapy
4. American Joint Committee on Cancer stage IIIA (T2N3a, T3N2, T4aN1, T4aN2, T4bN0), IIIB (T1N3b, T2N3b, T3N3a, T4aN3a, T4bN1, T4bN2), IIIC (T3N3b, T4aN3b, T4bN3a, T4bN3b), and has Lauren classification
5. with no evidence of metastatic disease
6. ECOG 0 to 1
7. Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
8. Woman of childbearing age should contracept for at least one month before screening and commit to using contraception throughout the entire study period and for the specified time after the study ends.
9. Signed informed consent and willing to follow the study protocol
Exclusion Criteria:
1. other primary malignancies, except for cured skin tumors or cervical carcinoma in situ
2. severe complications that may lead to an expected survival time less than 5 years
3. uncontrollable comorbidities, such as infectious disease, chronic diseases like hypertension, diabetes, heart diseases.
4. allergic to study medication
5. bowel obstruction or other conditions affecting oral administration
6. organ functions that cannot tolerate study treatment
7. other conditions that patients are unsuitable for this study assessed by the investigators
Primary outcome measure(s)
3-year disease-free survival rate — From randomization to 3 years after randomization Defined as the proportion of patients who remain free from recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause at 3 years after randomization.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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