Spots Global Cancer Trial Database for Immunotherapy With Racotumomab in Advanced Lung Cancer
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Trial Identification
Brief Title: Immunotherapy With Racotumomab in Advanced Lung Cancer
Official Title: A Prospective, Randomized, Multicenter, Open Label Phase III Study of Active Specific Immunotherapy With Racotumomab Plus Best Support Treatment Versus Best Support Treatment in Patients With Advanced Non-small Cell Lung Camcer.
Study ID: NCT01460472
Study Description
Brief Summary: This is a prospective, randomized, open label, parallel-group, multicenter phase III study to evaluate the efficacy and safety of active specific immunotherapy with racotumomab plus best supportive care versus best supportive care in patients with advanced NSCLC who have achieved an Objective Response (Partial or Complete Response) or Stable Disease with standard first-line treatment. Also immunological parameters will be evaluated. Best supportive therapy will be administered to all patients in the study according to institutional standards and includes any subsequent onco-specific therapies. 1082 patients will be included in the study, with non-small cell lung cancer in stages IIIA (non-resectable), IIIB or IV.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Instituto Médico CER, Quilmes, Buenos Aires, Argentina
Policlínica Privada Instituto de Medicina Nuclear, Bahía Blanca, , Argentina
Hospital Italiano, Córdoba, , Argentina
Hospital Privado de Córdoba, Córdoba, , Argentina
Instituto Oncológico de Córdoba, Córdoba, , Argentina
Fundación COIR, Mendoza, , Argentina
Centro Oncológico de Rosario, Rosario, , Argentina
ISIS Clinica Especializada, Santa Fe, , Argentina
NOB - Nucleo de Oncologia da Bahia, Salvador, BA, Brazil
CRIO - Centro Regional Integrado de Oncologia, Fortaleza, CE, Brazil
Hospital Universitário de Brasília, Brasília, DF, Brazil
Pro Onco - Centro de Tratamento Oncológico, Londrina, PR, Brazil
Hospital da Cidade de Passo Fundo, Passo Fundo, RS, Brazil
UPCO - Unidade de Pesquisas Clínicas em Oncologia, Pelotas, RS, Brazil
HCPA - Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil
Hospital de Base de São José do Rio Preto, São José do Rio Preto, SP, Brazil
Hospital Universitário de Brasília, Brasília - DF, , Brazil
Centro de Oncologia do Parana, Curitiba, , Brazil
CRIO - Centro Regional Integrado de Oncologia, Fortaleza - CE, , Brazil
Hospital Amaral de Carvalho, Jau, , Brazil
Pro Onco - Centro de Tratamento Oncológico, Londrina - PR, , Brazil
Centro Oncologico de Mogi das Cruzes, Mogi das Cruzes, , Brazil
Liga Norte Riograndense Contra o Cancer, Natal, , Brazil
Hospital da Cidade de Passo Fundo, Passo Fundo - RS, , Brazil
UPCO - Unidade de Pesquisas Clínicas em Oncologia, Pelotas - RS, , Brazil
HCPA - Hospital de Clínicas de Porto Alegre, Porto Alegre - RS, , Brazil
Hospital Moinhos de Vento, Porto Alegre, , Brazil
Oncologistas Associados, Rio de Janeiro, , Brazil
NOB - Nucleo de Oncologia da Bahia, Salvador - BA, , Brazil
Faculdade de Medicina do ABC, Santo Andre, , Brazil
GRAM - Grupo de Assistencia Medica e Prestacao de Servicos, Sao Paulo, , Brazil
Hospital de Base de São José do Rio Preto, São José do Rio Preto, , Brazil
Hospital "Hermanos Ameijeiras", Havana, , Cuba
Hospital "Celestino Hernández Robau", Provincia de Villa Clara, , Cuba
Hospital Jose Ramon Lopez Tabranes, Versalles, , Cuba
Dr Moewardi Hospital, Central Java, , Indonesia
Persahabatan Hospital, Jakarta, , Indonesia
RS Kanker 'Dharmais', Jakarta, , Indonesia
Dr Soetomo Hospital, Surabaya, , Indonesia
Dr Sardjito Hospital, Yogyakarta, , Indonesia
Perpetual Succour Hospital, Cebu City, , Philippines
Veterans Memorial Medical Center, Manila, , Philippines
Johns Hopkins Singapore International Medical Centre, Singapore, , Singapore
Chiang Mai Hospital, Chiang Mai, , Thailand
Khon Kaen Hospital, Division of Pulmonary and Critical Care Medicine, Khon Kaen, , Thailand
Songklanagarind Hospital - HOCC-PSU, Songkhla, , Thailand
Contact Details
Name: Roberto Gomez, M.D.
Affiliation: Recombio S.L.
Role: STUDY_DIRECTOR
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