Esophageal Cancer Clinical Trial
Official title:
Phase I Study of S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over 30 fractions,and concurrent with s-1 and nedaplatin.
Purpose: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 in
combination with nedaplatin and thoracic radiotherapy in patients with advanced esophageal
Cancer.
Methods: Thoracic radiation therapy was administered in 2Gy fractions five times weekly to a
total dose of 60 Gy.Concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on Days
1, and s-1 was given on Days 1-14,repeated every 4 weeks for four cycles. The dose of s-1
was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this
regimen.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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