Actively Recruiting
Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer After D2 Gastrectomy DRAGON-Adjuvant Study
Led by Ruijin Hospital · Updated on 2026-01-26
387
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating adjuvant chemotherapy for patients with stage III gastric cancer who have undergone D2 gastrectomy and achieved R0 resection. This phase 3, open-label, randomized study compares the effects of oxaliplatin plus S-1 versus docetaxel plus S-1 on disease-free survival. The study aims to provide direct comparison of these two chemotherapy regimens, focusing on their safety profiles, treatment duration, and patient adherence. Participants are randomly assigned to one of two treatment groups. The first group receives eight 3-week cycles of intravenous oxaliplatin with oral S-1 doses adjusted by body surface area. The second group receives oral S-1 for the first cycle, followed by six cycles of intravenous docetaxel plus oral S-1, and then continues oral S-1 for up to one year. The treatments are given after surgery, and the study includes follow-up for five years. During the study, participants undergo monitoring for disease recurrence and overall survival, along with safety assessments over approximately six months of treatment. The main outcome measured is the 3-year disease-free survival rate, with secondary outcomes including 5-year overall survival, safety profiles, and recurrence sites. The study will track patients closely with regular evaluations throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old, male or female
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- Underwent standard D2 gastrectomy with R0 resection and no prior systemic therapy
- Pathological stage IIIA, IIIB, or IIIC gastric cancer with Lauren classification
- No evidence of metastatic disease
- ECOG performance status 0 to 1
- Adequate organ function to tolerate treatment, including specified blood counts and liver, kidney function
- Women of childbearing age must use contraception before and during the study and for a set time after
- Signed informed consent and willingness to follow study protocol
You will not qualify if you...
- Other primary cancers except cured skin tumors or cervical carcinoma in situ
- Severe complications expected to limit survival to less than 5 years
- Uncontrolled comorbidities such as infectious diseases, hypertension, diabetes, or heart disease
- Allergy to study medications
- Bowel obstruction or conditions affecting oral drug intake
- Organ dysfunction preventing tolerance of study treatment
- Any other condition making the patient unsuitable for the study as assessed by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants receive adjuvant chemotherapy with either oxaliplatin plus S-1 or docetaxel plus S-1 after surgery.
Eight 3-week cycles with intravenous and oral medication; additional oral S-1 treatment cycles up to 1 year for the docetaxel plus S-1 group
Duration - Up to 5 years
Participants are followed for up to 5 years after surgery to monitor disease-free survival, overall survival, and recurrence.
Regular visits scheduled during follow-up period
Trial Site Locations
Total: 5 locations
1
Yuebei People's Hospital
Shaoguan, Guandong, China
Not Yet Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, China
Not Yet Recruiting
3
Renji Hospital
Shanghai, China
Not Yet Recruiting
4
Ruijin Hospital
Shanghai, China
Actively Recruiting
5
Shanghai Tenth People's Hospital
Shanghai, China
Not Yet Recruiting
Research Team
C
Chenfei Zhou, MD, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here