drugset / Trial / NCT01345084

Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab

NCT01345084

Phase 3 Withdrawn Eurofarma Laboratorios S.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary: to compare the overall survival defined as the time elapsed between the randomization date and death due to any cause, in both treatment groups. Secondary: to compare the progression-free survival, incidence of locoregional failure, site of the first recurrence/progression, objective response rate assessment, quality of life assessment and incidence of adverse events.

Timeline

Start
2013-11
Primary completion
2013-11
Completion
2017-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Nimotuzumab Monoclonal antibody 200 mg Intravenous
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous