NCT01732380

A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer

A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: The First People's Hospital of Lianyungang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.

Detailed description

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.

Conditions

• Inoperable Esophageal Cancer Stage I-III

Interventions

Type	Name	Description
DRUG	Raltitrexed
DRUG	Oxaliplatin
RADIATION	Radiotherapy

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-11-22
• Last updated: 2012-11-22

Locations

1 site across 1 country: China