drugset / Trial / NCT01249352

A Study of Chemoradiation Associated with Nimotuzumab As the Treatment of Locally Advanced Esophageal Cancer

NCT01249352

Phase 2/3 Completed 104 enrolled Eurofarma Laboratorios S.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to assess the efficacy of nimotuzumab in combination with chemotherapy and radiotherapy for the treatment of locally advanced esophageal cancer, comparing it to that of the conventional treatment with radiation and chemotherapy. The secondary objective of this study is to assess the health-related quality of life for the nimotuzumab in combination with chemotherapy and radiotherapy regimen, compared to the standard chemoradiation regimen in the treatment of inoperable locally advanced esophageal cancer.

Timeline

Start
2009-01
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Nimotuzumab Monoclonal antibody 200 mg Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background fluorouracil Small molecule 1000 mg/m2 Intravenous