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RECRUITING
NCT07366528
PHASE3

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

387

Start Date

2025-12-15

Completion Date

2030-10-31

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

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.

Locations (5)

Yuebei People's Hospital

Shaoguan, Guandong, China

Fudan University Shanghai Cancer Center

Shanghai, China

Renji Hospital

Shanghai, China

Ruijin Hospital

Shanghai, China

Shanghai Tenth People's Hospital

Shanghai, China