Actively Recruiting
Perioperative FLOT vs Adjuvant XELOX for CA Stomach
Led by Chinese University of Hong Kong · Updated on 2023-09-07
110
Participants Needed
1
Research Sites
301 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Perioperative FLOT vs Adjuvant XELOX for CA Stomach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Locally advanced adenocarcinoma of stomach or esophagogastric junction (Siewert type II and III) with clinical stage �3E�3D T3 and/or �3E�3D N1 and no distant metastasis
- Surgically resectable disease based on clinical staging
- No previous gastrectomy or chemotherapy
- Age 18 or above but less than 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Hemoglobin level �3E�3D 8.0 g/dL
- Neutrophil count �3E�3D 1,500/�b5l
- Platelet count �3E�3D 100,000/�b5l
- Creatinine clearance �3E�3D 50 ml/min
- Serum albumin �3E 25 g/L
You will not qualify if you...
- Presence of distant metastases or tumor invasion to organs not operable by surgery
- Hypersensitivity or contraindication to Capecitabine, 5-FU, Leucovorin, Oxaliplatin, or Docetaxel
- Active coronary heart disease, cardiomyopathy, or cardiac insufficiency stage III-IV (NYHA classification)
- Peripheral polyneuropathy grade �3E�3D II (NCI grading)
- Severe liver dysfunction: ALT �3E 3 times upper limit of normal and/or total bilirubin �3E 1.5 times upper limit of normal (except Gilbert Syndrome with bilirubin up to 3 times normal)
- Pregnancy or breastfeeding
- Another malignant disease within the last 5 years (except adequately treated in situ cervical carcinoma or basal cell skin carcinoma)
- Serious uncontrolled infection or severe concurrent medical conditions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
H
Hon Chi Yip, FRCSEd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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