Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer
Summary
RESONANCE-II trial is a prospective, multicenter, randomized, controlled phase III study which will enroll 524 patients in total. Patients with eligibility will be registered, pre-enrolled and receive three cycles of SOX. Then, tumor response evaluation will be carried out. Those who achieve stable disease or progressive disease will be excluded. Patients achieving complete response or partial response will be enrolled and assigned into either group A for another three cycles of SOX (six cycles in total) followed by D2 surgery and group B for D2 surgery (three cycles in total). The primary endpoint is the rate of pathological complete response and the secondary endpoints are R0 resection rate, three-year disease-free survival, five-year overall survival and safety.
Timeline
- Start
- 2021-01-13
- Primary completion
- 2022-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | S-1 | Small molecule | 40 mg | Oral |
| Subject | S-1 | Small molecule | 50 mg | Oral |
| Subject | S-1 | Small molecule | 60 mg | Oral |