RecruitingPhase 3NCT07366528

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

Sponsor

Ruijin Hospital

Enrollment

387 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy regimens given after surgery for Stage III stomach (gastric) cancer: the standard oxaliplatin + S-1 combination versus docetaxel + S-1. The goal is to find out which gives patients a better chance of the cancer not returning. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with adenocarcinoma of the stomach or where the stomach meets the esophagus - You have already had surgery to remove the tumor with a full lymph node removal (D2 gastrectomy) and the surgeons got clear margins (R0 resection) - Your cancer is Stage III and has not spread to distant organs - You have not received chemotherapy or radiation before surgery - Your blood counts and organ function meet the required thresholds **You may NOT be eligible if...** - Your cancer has already spread to other organs (Stage IV) - You had prior chemotherapy or targeted therapy before surgery - Your organ function is not adequate to tolerate chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOxaliplatin 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).

DRUGDocetaxel 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.