Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab (NICAP)
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.
Head and Neck Cancer
Radiation: Radiation Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Study Evaluating the Standard Radiation Therapy and Chemotherapy Regimen, With or Without Nimotuzumab, in Unresectable, Locally Advanced Epidermoid Carcinoma of the Head and Neck|
- Overall survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Local control of disease will be measured by magnetic resonance imaging (MRI) and physical examination 6 weeks after treatment end.
- Complete clinical response rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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;
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Radiation therapy, cisplatin and nimotuzumab
Nimotuzumab - (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes. Pre-drugs are optional, at the investigator's discretion)- 200 mg, IV, weekly doses during the radiation therapy until completing 6 months.
Radiation therapy- 66 -70 Gy, external,fractions of 2 Gy per day, 5 days a week
Cisplatin - 75 mg/m2, IV, Doses every 3 weeks (a total of three doses)
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).
Active Comparator: Radiation therapy and cisplatin
Radiation therapy: 66- 70 Gy, fractions of 2 Gy per day, 5 days a week
Cisplatin:75 mg/m2, IV, doses every 3 weeks (a total of three doses)
Radiation: Radiation Therapy
66- 70 Gy External, Fractions of 2.0 Gy per day, 5 days a weekDrug: Cisplatin
75 mg/m2, IV, doses every 3 weeks (a total of three doses)
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345084
|Hospital Erasto Gaetner|
|Curitiba, Paraná, Brazil, 81520-060|
|Hospital de Clínicas de Porto Alegre|
|porto Alegre, Rio Grande do Sul, Brazil, 90035-903|
|Fundação Pio XII - Hospital de Câncer de Barretos|
|Barretos, São Paulo, Brazil, 14784-400|
|Hospital Amaral Carvalho|
|Jau, São Paulo, Brazil, 17210-120|
|Centro Oncológico de Mogi das Cruzes|
|Mogi das Cruzes, São Paulo, Brazil, 08730-500|
|Hospital de Base São José do Rio Preto|
|São José do Rio Preto, São Paulo, Brazil, 15090-000|
|Hospital Federal de Bonsucesso|
|Rio de Janeiro, Brazil, 210041-030|
|Instituto do Câncer de São Paulo|
|São Paulo, Brazil, 01246-000|
|Principal Investigator:||Gustavo Girotto||Hospital de Base São José do Rio Preto|