Recruitment

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