Status:
RECRUITING
Perioperative FLOT vs Adjuvant XELOX for CA Stomach
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Cancer of Stomach, Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 clinic...
Detailed Description
The use of perioperative chemotherapy / chemoradiation for locally advanced cancer of the stomach and esophagogastric junction has been advocated in the past 2 decades. Randomized studies from Asia, E...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Surgically resectable disease based on clinical staging
- No previous gastrectomy or chemotherapy
- Age 18 or above but less than 80, and
- ECOG ≤2
- Hemoglobin \>/= 8.0 g/dL
- Neutrophils \>/= 1.500/µl
- Platelets ≥ 100.000/µl
- Creatinine clearance ≥ 50 ml/min
- Serum albumin \>25 g/L
- Exclusion criteria:
- Distant metastases, direct tumor invasion to organs not resectable by surgery
- Hypersensitivity or contraindication against Capacitabine, 5-FU, Leucovorin, Oxaliplatin, Docetaxel
- Active CHD, Cardiomyopathy or cardiac insufficiency stage III-IV according to NYHA
- Peripheral polyneuropathy ≥ NCI grade II
- 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)
- Pregnancy or lactation
- Malignant secondary disease, dated back \<5 years (except in-situ carcinoma of cervix uteri, adequately treated skin basal cell carcinoma)
- Serious uncontrolled infection or cocomitant severe medical conditions
Exclusion
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05264896
Start Date
March 21 2022
End Date
December 31 2027
Last Update
September 7 2023
Active Locations (1)
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1
The Chinese University of Hong Kong
Hong Kong, Hong Kong