Perioperative FLOT vs Adjuvant XELOX for CA Stomach

Summary

This is a single centre randomised controlled trial, comparing perioperative FLOT versus adjuvant XELOX for locally advanced gastric and esophagogastric junction cancers. Patients with operable clinical T3 or above and N1 or above gastric and esophagastric junction cancer would be recruited. Participants would be randomised to perioperative FLOT versus adjuvant XELOX with curative radical gastrectomy. Primary outcome would be 3 year Disease Free Survival. It was calculated that 110 patients would be required to demonstrate the study hypothesis.

Eligibility

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

Conditions2

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