A Multicenter Randomized Phase-II Study Of 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
Progression-free survival (PFS) is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse.
up to 2 years
Xiaodong Jiang, Doctor
The First People`s Hospital of Lianyungang
China: Food and Drug Administration