Perioperative FLOT vs Adjuvant XELOX for CA Stomach
ConditionCancer of Stomach, Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 5-FU, Leucovorin, Oxaliplatin, Docetaxel
- XELOX
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov