Comparing Docetaxel and Oxaliplatin with S-1 for Gastric Cancer Treatment
S-1 Plus Docetaxel(DS) Versus S-1 Plus Oxaliplatin(SOX) as Postoperative Therapy for Stage II / III Gastric Cancer, a Randomized Controlled Trial
This study is testing whether a combination of two different chemotherapy treatments can help people with stage II or III stomach cancer live longer and feel better after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT03961867 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of two chemotherapy regimens for patients with stage II or III gastric adenocarcinoma following D2 surgical resection. Participants will be randomly assigned to receive either S-1 combined with docetaxel or S-1 combined with oxaliplatin. The primary goal is to assess disease-free survival, while secondary outcomes include overall survival, safety, and quality of life. Patients aged 18 to 75 with adequate organ function and specific performance status will be eligible for this study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with stage II or III gastric adenocarcinoma who have undergone D2 resection.
Not a fit: Patients with a history of other malignancies or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective chemotherapy option for patients with advanced gastric cancer, potentially improving survival rates.
How similar studies have performed: Previous studies have shown promising results with S-1 in combination with oxaliplatin, but the combination with docetaxel is being explored in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * informed consensus of patients * be able to receive oral administration * from 18 to 75 years old * be proven to be primary adenocarcinoma of stomach and staged II or III by pathological evidences * without other chemotherapy and/or radiation against to the disease * normal function of other organs including heart,liver ,kidney and so on * Eastern Cooperative Oncology Group performance status:0\~2 Exclusion Criteria: * history of other malignancy * allergic reaction to S-1 or oxaliplatin of docetaxel * be enrolling in other clinical trials * abnormal GI tract function * dysfunction of other organs * female in pregnancy or lactation,or refuse to receive Contraception measures during chemotherapy * other situation to be judged not adaptive to the study by investigators
Where this trial is running
Guangzhou
- Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Jian Xiao, MD — Sixth Affiliated Hospital, Sun Yat-sen University
- Study coordinator: Shanshan Li, MD
- Email: lishsh89@163.com
- Phone: 86-20-38285497
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.