Docetaxel Versus Oxaliplatin as Addition to S-1 for Stage II / III Gastric Adenocarcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 622
Summary
- Conditions
- Gastric Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
In this study, patients with gastric or EGJ adenocarcinoma who received D2 dissection and staged II or III, aged from 18 to 75 years and with ECOG PS ?2 and adequate organ function, are stratified randomized according to pstage and location of primary lesion. Group DS: S-1 is orally administer by BS...
In this study, patients with gastric or EGJ adenocarcinoma who received D2 dissection and staged II or III, aged from 18 to 75 years and with ECOG PS ?2 and adequate organ function, are stratified randomized according to pstage and location of primary lesion. Group DS: S-1 is orally administer by BSA (<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively. Docetaxel 40mg/m2/3w from the second to the seventh cycles. Group SOX: S-1 is orally administer by BSA (<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively. Oxaliplatin 130mg/m2/3w from the first to the eight cycles. The primary end point is disease-free survival(DFS). The overall survival (OS), safty and quality of life are secondary end points.
Tracking Information
- NCT #
- NCT03961867
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jian Xiao, MD Sixth Affiliated Hospital, Sun Yat-sen University