The primary objective of this study is to assess the efficacy of nimotuzumab in combination with chemotherapy and radiotherapy for the treatment of locally advanced esophageal cancer, comparing it to that of the conventional treatment with radiation and chemotherapy. The secondary objective of this study is to assess the health-related quality of life for the nimotuzumab in combination with chemotherapy and radiotherapy regimen, compared to the standard chemoradiation regimen in the treatment of inoperable locally advanced esophageal cancer.
This will be a phase II, randomized, controlled, open-label, multicenter, and two-arm study. The study will be conducted in Brazil and has the purpose of determining the activity and safety of nimotuzumab in terms of overall survival, TTP, clinical and endoscopic response rates, resectability rate, toxicity profile, and quality of life. All participating patients will sign a consent form before they undergo any study-related procedure. The eligible patients will have locally advanced esophageal cancer, and they will be randomized to one of two treatment groups. Randomization will be centrally coordinated by the sponsor and performed by means of the electronic CRF itself.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
200 mg, IV Weekly IV dose for up to 26 weeks.
75 mg/m2, IV dose on D1 of each chemotherapy cycle, for 4 cycles, always after nimotuzumab.
1,000 mg/m2, IV dose in a 24-hour continuous infusion, from D1 to D4, every chemotherapy cycle, for 4 cycles.
Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day
Hospital Evangélico do Cachoeiro do Itapemirim
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Hospital Universitário de Brasília
Brasília, Federal District, Brazil
Santa Casa de Misericórdia de BH
Belo Horizonte, Minas Gerais, Brazil
Hospital Erasto Gaetner
Curitiba, Paraná, Brazil
Hospital Geral de Bonsucesso
Rio de Janeiro, Rio de Janeiro, Brazil
Instituto Nacional do Câncer (INCA)
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital da cidade de Passo Fundo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Novos Tratamentos de Itajaí
Itajaí, Santa Catarina, Brazil
...and 9 more locations
Overall survival and assessment of the complete endoscopic response
The primary endpoint of this study is the overall survival at the end of Phase II. At the end of Phase II, the assessment of the complete endoscopic response, and the regimen safety will be used to decide if the study will continue to Phase III.
Time frame: 2 years
Complete clinical response rate
* Time to tumor progression (TTP); * Complete clinical response rate, defined as the proportion of patients with absence of visible disease in the high endoscopy and in the chest and abdomen computerized tomography, in the population assessable for response; * Complete endoscopic response rate, defined as the absence of visible disease in the high endoscopy; * Resectability rate; * Safety: * Quality of life, according to the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire; * Relationship between efficacy and safety and the tumor characteristics.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.