OncoMatch/Clinical Trials/NCT05264896
Perioperative FLOT vs Adjuvant XELOX for CA Stomach
Is NCT05264896 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including 5-FU, Leucovorin, Oxaliplatin, Docetaxel and XELOX for cancer of stomach, adenocarcinoma.
Treatment: 5-FU, Leucovorin, Oxaliplatin, Docetaxel · XELOX — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage ≥T3, ≥N1
defined by clinical stage ≥T3 and/or ≥N1, in the absence of distant metastasis
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
No previous chemotherapy
Cannot have received: surgery (gastrectomy)
No previous gastrectomy
Lab requirements
Blood counts
Hemoglobin ≥ 8.0 g/dL; Neutrophils ≥ 1,500/µl; Platelets ≥ 100,000/µl; Serum albumin >25 g/L
Kidney function
Creatinine clearance ≥ 50 ml/min
Liver function
ALT >3 x upper limit of normal, and/or 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)
Cardiac function
Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA [excluded]
Hemoglobin ≥ 8.0 g/dL; Neutrophils ≥ 1,500/µl; Platelets ≥ 100,000/µl; Creatinine clearance ≥ 50 ml/min; Serum albumin >25 g/L; Severe liver dysfunction (ALT >3 x ULN, and/or total bilirubin >1.5 x ULN); Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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