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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.

Phase 3RecruitingChinese University of Hong KongNCT05264896Data as of May 2026

Treatment: 5-FU, Leucovorin, Oxaliplatin, Docetaxel · XELOXThis 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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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