Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

November 30, 2013

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2017

Conditions
CarcinomaHead and Neck Cancer
Interventions
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)

Trial Locations (8)

81520-060

Hospital Erasto Gaetner, Curitiba

210041-030

Hospital Federal de Bonsucesso, Rio de Janeiro

90035-903

Hospital de Clínicas de Porto Alegre, Porto Alegre

14784-400

Fundação Pio XII - Hospital de Câncer de Barretos, Barretos

17210-120

Hospital Amaral Carvalho, Jaú

08730-500

Centro Oncológico de Mogi das Cruzes, Mogi das Cruzes

15090-000

Hospital de Base São José do Rio Preto, São José do Rio Preto

01246-000

Instituto do Câncer de São Paulo, São Paulo

Sponsors
All Listed Sponsors
lead

Eurofarma Laboratorios S.A.

INDUSTRY