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Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer

Study acronym: RESONANCE-II
StatusRecruiting
PhasePhase 3
Started2021-01-13
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 20, 2021 (before its estimated December 2022 completion). Its status may not reflect the trial's current state.

Amendment history

2021-01-17
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-09→confirmed 2021-01-13
Study sites0→1
2020-07-22
Original filing
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.
Trial Details
NCT Number NCT04483076
Lead Sponsor Chinese PLA General Hospital
Conditions Gastric Cancer, Chemotherapy Effect
Enrollment 524 participants
Start Date 2021-01-13
Primary Completion 2022-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2021-01-20