A Phase II, Randomized, Controlled, Open-Label Study Comparing Standard Chemoradiation Versus Chemoradiation Associated With Nimotuzumab as the Treatment of Locally Advanced Esophageal Cancer
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 survival, TTP, clinical and endoscopic response
rates, resectability rate, toxicity profile, and quality of life. All participating patients
will sign a consent form before they undergo any study-related procedure. The eligible
patients will have locally advanced esophageal cancer, and they will be randomized to one of
two treatment groups. Randomization will be centrally coordinated by the sponsor and
performed by means of the electronic CRF itself.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival and assessment of the complete endoscopic response
The primary endpoint of this study is the overall survival at the end of Phase II. At the end of Phase II, the assessment of the complete endoscopic response, and the regimen safety will be used to decide if the study will continue to Phase III.
Brazil: National Committee of Ethics in Research