A Phase II, Multicenter, Randomized,Two-Arm Clinical Study: An Investigational Arm Containing Nimotuzumab in Combination With Radiotion Therapy and Cisplatyn, and a Control Arm With Radiation Therapy and Cisplatin for the Definitive Treatment of Stage IB and IVA Uterine Cervical Carcinoma
This will be a phase II, randomized, controlled, open-label, multicenter, and two-arm study.
The study will be conducted in Brazil and has the purpose of determining the activity and
safety of nimotuzumab in terms of overall and distant disease-free survival, radiological
and clinical gynecological examinations, as well as by biopsy, if indicated,
progression-free survival, local control of long-term disease, frequency of
treatment-emergent adverse events, frequency of severe treatment-emergent adverse events.
All participating patients will sign a consent form before they undergo any study-related
procedure.The eligible patients will have stage IB and IVA uterine cervical carcinoma and
they will be randomized to one of two treatment groups.
Randomization and treatment assignment will be performed by a company specifically
contracted for such purpose and will be per research site and disease stage (IB2 to IIIA
versus IIIB to IVA), 1:1.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Local control of disease
Local control of disease will be measured by magnetic resonance imaging (MRI), clinical gynecological examinations, as well as by biopsy (if indicated), 12 weeks after treatment end.
Núcleo de Novos Tratamentos em Câncer - NNTC
Brazil: National Committee of Ethics in Research