NCT01345084

Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Carcinoma
• Head and Neck Cancer

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	66- 70 Gy External, Fractions of 2.0 Gy per day, 5 days a week
DRUG	Nimotuzumab	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).
DRUG	Cisplatin	75 mg/m2, IV, doses every 3 weeks (a total of three doses)

Timeline

• Start date: 2013-11-01
• Primary completion: 2013-11-01
• Completion: 2017-11-01
• First posted: 2011-04-29
• Last updated: 2025-03-28

Locations

8 sites across 1 country: Brazil