NCT07366528

Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer

Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer After D2 Gastrectomy (DRAGON-Adjuvant): a Multicenter, Open-label, Phase 3, Randomized, Non-inferiority Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 387 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, phase 3, randomized, non-inferiority study aimed to investigate the effect on disease-free survival of adjuvant chemotherapy with oxaliplatin plus S-1 compared with adjuvant chemotherapy with docetaxel plus S-1 after D2 gastrectomy in patients with stage III gastric cancer.

Detailed description

In gastric cancer, adjuvant chemotherapy that can reduce the risk of recurrence and improve patient survival has been a standard of care for gastric cancer patients with pathological stage II-III after D2 gastrectomy and R0 resection. Currently, oxaliplatin plus S-1 (SOX) or docetaxel plus S-1 (DS) have been recommended as adjuvant therapy for stage III gastric cancer patients, based on the results of RESOLVE trial and JACCRO GC-07 trial, respectively. However, due to the different study design and patient enrollment, the efficacy of these two regimens can hardly be compared directly. The safety profiles and treatment period of the two regimens can be factors to guide regimen selection. For SOX regimen, oxaliplatin-related peripheral neuropathy and allergy are clinical concerned issues. Although frequency of similar toxicities of docetaxel is lower, S-1 should be administrated for 12 months after surgery in the DS regimen. Prolonged treatment period also increases the risk of treatment-related toxicities and impairs patients' adherence. There is necessary to compare these two regimens directly. In this study, gastric cancer patients who undergo D2 gastrectomy and achieve R0 resection with pathological stage III (IIIA, IIIB, IIIC) will be randomized and treated with SOX or DS regimen. In SOX group, eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (\<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; \>1.5m2 60mg twice a day, days 1 to 14 of each cycle). In DS group, S-1 dose is also determined by body surface area. Patients are treated with S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year. Patients will be followed up for 5 years after surgery.

Conditions

• Gastric Cancer (GC)
• Adjuvant Chemotherapy
• Stage 3 Cancer
• Docetaxel
• Oxaliplatin

Interventions

Type	Name	Description
DRUG	Oxaliplatin plus S-1	SOX group: eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (\<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; \>1.5m2 60mg twice a day, days 1 to 14 of each cycle).
DRUG	Docetaxel plus S-1	DS group: S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year.

Timeline

• Start date: 2025-12-15
• Primary completion: 2028-10-30
• Completion: 2030-10-31
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

5 sites across 1 country: China