A Phase 3 interventional study of Radiation Therapy and Nimotuzumab in Carcinoma and Head and Neck Cancer, sponsored by Eurofarma Laboratorios S.A.. Withdrawn at 8 sites in Brazil. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Eurofarma Laboratorios S.A. · Phase 3, Interventional, and Treatment
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
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
Browse Carcinoma studies →Eurofarma Laboratorios S.A. is the lead sponsor of 64 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
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)
Drug: Nimotuzumab
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 · Drug: Cisplatin
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)
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 study is withdrawn, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eurofarma Laboratorios S.A.