Clinical trial · Interventional
Perioperative FLOT vs Adjuvant XELOX for CA Stomach
Perioperative FLOT Versus Adjuvant XELOX for Locally Advanced Gastric Cancer - a Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Stomach, Adenocarcinoma | Malignant Gastric Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU, Leucovorin, Oxaliplatin, Docetaxel | Drug | — | UNRESOLVED |
| XELOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FLOT
- description
- Patients randomized to the FLOT arm would receive perioperative FLOT Regimen: * Docetaxel 50mg/m2, d1 * 5-FU 2600 mg/m², d1 * Leucovorin 200 mg/m², d1 * Oxaliplatin 85 mg/m², d1 * Every two weeks 4 cycles pre-op and 4 cycles post-op Granulocyte colony stimulating factor (GCSF) at 30 mu s.c. daily from Day 4 to Day 7 is recommended. Two weeks after completion of the 4 cycles of pre-op chemotherapy, reassessment endoscopy and CT scan would be performed. Surgery would be performed 4 weeks after pre-op chemotherapy if no distant metastasis was found on CT scan. Post-op adjuvant FLOT (x 4 cycles) will be started within 10 weeks after surgery.
- interventionNames
- Drug: 5-FU, Leucovorin, Oxaliplatin, Docetaxel
- type
- ACTIVE_COMPARATOR
- label
- XELOX
- description
- Patients randomized to adjuvant XELOX arm would receive chemotherapy after surgery. * Capecitabine - 1,000 mg/m² twice daily. * Oxaliplatin - IV infusion, 130mg/m²
- interventionNames
- Drug: XELOX
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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