Using metronomic capecitabine for stage III gastric cancer treatment
Metronomic Capecitabine as Adjuvant Therapy in Stage III Gastric Cancer: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 3 Trial
This study is testing if a new way of giving capecitabine, a chemotherapy drug, can help people with stage III gastric cancer live longer after their standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 722 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06313567 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of metronomic capecitabine in improving survival rates for patients with stage III gastric cancer who have already undergone standard treatment. Participants will receive metronomic capecitabine, a chemotherapy regimen administered in a continuous low-dose manner, while a control group will be observed without additional treatment. The study will include patients aged 18 to 80 years who have undergone R0 gastrectomy with D2 lymphadenectomy and have a good performance status. The trial seeks to determine if this innovative approach can enhance patient outcomes compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with stage III primary adenocarcinoma of the stomach who have undergone appropriate surgical resection.
Not a fit: Patients with stage IV gastric cancer or those who have previously received chemotherapy or other treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients with stage III gastric cancer.
How similar studies have performed: While the use of metronomic chemotherapy is an emerging approach, similar studies have shown promise in other cancer types, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old. 2. Be proven to be primary adenocarcinoma of gastric cancer and staged III by pathological evidences 3. R0 gastrectomy with D2 lymphadenectomy 4. ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months 5. No contraindications, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥3.5 x 109 /L, NEU≥1.2 x 109 /L,PLT≥90 x 109 /L and HGB≥80g/L). Exclusion Criteria: 1. History of chemotherapy, radiotherapy, immunotherapy or target therapy 2. Multiple primary tumors 3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases 4. Unavailable for R0 resection and D2 lymph node dissection. 5. Patients with stage IV gastric cancer
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jing Guo, MD
- Email: gjsysu@126.com
- Phone: 021-64175590
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.