Inoperable Esophageal Cancer Stage I-III Clinical Trial
Official title:
A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.
108 patients were randomized to receive Raltitrexed/Oxaliplatin Plus Radiotherapy (Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks.)or Radiotherapy ( Radiotherapy 2.0Gy/day, 5 times/week,6 weeks) in subjects with Inoperable esophageal cancer. All patients will receive therapy of six weeks unless disease progression or unacceptable toxicity. Patients were evaluated every 3 months .Progression-Free-Survival was the primary endpoint. Response Rate, Overall survival, toxicity of the therapy are other second endpoint. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment