Comparing two chemotherapy regimens for advanced stomach cancer
Perioperative FLOT Versus Adjuvant XELOX for Locally Advanced Gastric Cancer - a Randomized Controlled Study
This study is testing which of two chemotherapy treatments works better for people with advanced stomach cancer before and after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05264896 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single-center randomized controlled trial that compares perioperative FLOT chemotherapy with adjuvant XELOX for patients with locally advanced gastric and esophagogastric junction cancers. Eligible participants will be those with operable clinical T3 or above and N1 or above cancer, who will be randomized to receive either treatment followed by radical gastrectomy. The primary outcome measure is the three-year disease-free survival rate, with a target enrollment of 110 patients to validate the study hypothesis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with locally advanced adenocarcinoma of the stomach or esophagogastric junction who are eligible for surgical resection.
Not a fit: Patients with distant metastases or those with significant comorbidities that contraindicate the use of the chemotherapy agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve disease-free survival rates for patients with advanced gastric cancer.
How similar studies have performed: Previous studies have shown success with perioperative chemotherapy approaches, indicating a promising avenue for treatment in this patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Locally advanced adenocarcinoma of stomach or esophagogastric junction (Siewert type II and III), defined by clinical stage ≥T3 and/or ≥N1, in the absence of distant metastasis 2. Surgically resectable disease based on clinical staging 3. No previous gastrectomy or chemotherapy 4. Age 18 or above but less than 80, and 5. ECOG ≤2 6. Hemoglobin \>/= 8.0 g/dL 7. Neutrophils \>/= 1.500/µl 8. Platelets ≥ 100.000/µl 9. Creatinine clearance ≥ 50 ml/min 10. Serum albumin \>25 g/L Exclusion criteria: 1. Distant metastases, direct tumor invasion to organs not resectable by surgery 2. Hypersensitivity or contraindication against Capacitabine, 5-FU, Leucovorin, Oxaliplatin, Docetaxel 3. Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA 4. Peripheral polyneuropathy ≥ NCI grade II 5. Severe liver dysfunction (i) ALT \>3 x upper limit of normal, and/ or (ii) total bilirubin \>1.5 x upper limit of normal (subjects with Gilbert Syndrome with total bilirubin level of \>/= 3.0 x upper limit of normal) 6. Pregnancy or lactation 7. Malignant secondary disease, dated back \<5 years (except in-situ carcinoma of cervix uteri, adequately treated skin basal cell carcinoma) 8. Serious uncontrolled infection or cocomitant severe medical conditions
Where this trial is running
Hong Kong
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Hon Chi Yip, FRCSEd — Chinese University of Hong Kong
- Study coordinator: Hon Chi Yip, FRCSEd
- Email: hcyip@surgery.cuhk.edu.hk
- Phone: 35052627
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.