Comparing oxaliplatin plus S-1 versus docetaxel plus S-1 after surgery for stage III stomach 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
This trial tests whether oxaliplatin plus S-1 or docetaxel plus S-1 is better at preventing cancer recurrence in people with stage III gastric cancer after D2 gastrectomy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 387 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Shaoguan, Guandong and 4 other locations) |
| Trial ID | NCT07366528 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, open-label, randomized non-inferiority phase 3 trial enrolling patients with pathological stage III gastric or gastroesophageal junction adenocarcinoma who underwent D2 gastrectomy with R0 resection. Participants are randomly assigned to receive either oxaliplatin plus oral S-1 (SOX) or docetaxel plus oral S-1 (DS) as adjuvant chemotherapy, following the dosing schedules used in prior trials. The primary endpoint is disease-free survival, with safety and tolerability compared between regimens, paying attention to oxaliplatin-related neuropathy and the longer S-1 exposure in the DS arm. Regular clinic visits are required for intravenous infusions, oral drug monitoring, and follow-up imaging.
Who should consider this trial
Good fit: Adults 18–80 years old with histologically confirmed stage III gastric or gastroesophageal junction adenocarcinoma who had D2 gastrectomy with R0 resection, ECOG 0–1, no prior systemic therapy, no metastases, and adequate organ function are ideal candidates.
Not a fit: Patients with metastatic disease, prior neoadjuvant systemic therapy, poor performance status (ECOG >1), significant organ dysfunction, or non-stage III disease are unlikely to benefit from this adjuvant comparison.
Why it matters
Potential benefit: If successful, the trial could identify an adjuvant regimen that provides similar cancer control with a preferable side-effect profile or shorter treatment duration, helping patients and doctors choose the best option.
How similar studies have performed: Previous trials (RESOLVE and JACCRO GC-07) supported the use of SOX and DS individually as adjuvant options, but a direct head-to-head comparison like this is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age 18 to 80 years old, male and female 2. histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction 3. patients underwent standard D2 gastrectomy and achieved R0 resection, and had no systemic therapy like neoadjuvant therapy 4. American Joint Committee on Cancer stage IIIA (T2N3a, T3N2, T4aN1, T4aN2, T4bN0), IIIB (T1N3b, T2N3b, T3N3a, T4aN3a, T4bN1, T4bN2), IIIC (T3N3b, T4aN3b, T4bN3a, T4bN3b), and has Lauren classification 5. with no evidence of metastatic disease 6. ECOG 0 to 1 7. Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN. 8. Woman of childbearing age should contracept for at least one month before screening and commit to using contraception throughout the entire study period and for the specified time after the study ends. 9. Signed informed consent and willing to follow the study protocol Exclusion Criteria: 1. other primary malignancies, except for cured skin tumors or cervical carcinoma in situ 2. severe complications that may lead to an expected survival time less than 5 years 3. uncontrollable comorbidities, such as infectious disease, chronic diseases like hypertension, diabetes, heart diseases. 4. allergic to study medication 5. bowel obstruction or other conditions affecting oral administration 6. organ functions that cannot tolerate study treatment 7. other conditions that patients are unsuitable for this study assessed by the investigators
Where this trial is running
Shaoguan, Guandong and 4 other locations
- Yuebei People's Hospital — Shaoguan, Guandong, China (Not_yet_recruiting)
- Fudan University Shanghai Cancer Center — Shanghai, China (Not_yet_recruiting)
- Renji Hospital — Shanghai, China (Not_yet_recruiting)
- Ruijin Hospital — Shanghai, China (Recruiting)
- Shanghai Tenth People's Hospital — Shanghai, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Chenfei Zhou, MD, Ph.D
- Email: zcf12085@rjh.com.cn
- Phone: +86-21-64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.