Phase I Study of S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of s-1 in combination with nedaplatin and thoracic radiotherapy
the MTD will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) during treatment.
3 months per patient
Yes
Xianghui Du, MD
Study Chair
Zhejiang Cancer Hospital
China: Food and Drug Administration
ZhejiangCH08
NCT01175460
January 2010
January 2011
Name | Location |
---|