drugset / Trial / NCT01301612

Study of Nimotuzumab, Radiation Therapy and Cisplatin Versus Radiation Therapy and Cisplatin for Treatment of Stage IB e IVA UCC(CORUS)

NCT01301612

Phase 2 Withdrawn Eurofarma Laboratorios S.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary study objective will be to assess the efficacy of the combination of radiation therapy with nimotuzumab and cisplatin, as compared to the combination of radiation therapy plus cisplatin in the treatment of Uterine Cervical Carcinoma (UCC). The secondary study objectives will be safety and tolerability evaluations, to determine treatment feasibility and the interim efficacy evaluation according to other parameters routinely used in oncology.

Timeline

Start
2011-01
Primary completion
2017-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Nimotuzumab Monoclonal antibody 200 mg Intravenous
Comparator Cisplatin Other / unclassified 40 mg/m2 Intravenous