Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT03961867
Brief Summary:
S-1 plus oxaliplatin has been proved better than S-1 alone for stage II or III gastric cancer.
Docetaxel also showed excellent efficacy with S-1 in the postoperative setting for stage III gastric cancer.
This trial is designed to investigate the efficacy and safety of S-1 plus docetaxel versus S-1 plus oxalipltin as adjuvant chemotherapy after D2 resection in stage II / III gastric cancer.
Detailed 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 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.
Study:
NCT03961867
Study Brief:
Protocol Section:
NCT03961867