Comparing two chemotherapy regimens for advanced stomach cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.