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.
This is a phase III, superiority, national, open-label, randomized, and two-arm study. Patients' enrollment will be performed only after approval by competent regulatory authorities and it will last up to 12 months. All patients taking part in the study must sign an informed consent. The patients will have stage III or IV, unresectable head and neck SCC, performance status 0 or 1. Randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage, 1:1
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
66- 70 Gy External, Fractions of 2.0 Gy per day, 5 days a week
200 mg, IV, weekly doses during the radiation therapy until completing 6 months (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes).
75 mg/m2, IV, doses every 3 weeks (a total of three doses)
Hospital Erasto Gaetner
Curitiba, Paraná, Brazil
Hospital Federal de Bonsucesso
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Overall survival
Local control of disease will be measured by magnetic resonance imaging (MRI) and physical examination 6 weeks after treatment end.
Time frame: 6 months
Complete clinical response rate
Progression-free survival; Incidence of locoregional failure; Site of the first recurrence or progression; Objective response rate assessment; EORTC quality of life questionnaires assessment; Incidence of several adverse events;
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Barretos, São Paulo, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
Centro Oncológico de Mogi das Cruzes
Mogi das Cruzes, São Paulo, Brazil
Hospital de Base São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Instituto do Câncer de São Paulo
São Paulo, São Paulo, Brazil