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Public trial
 

                                        

                    

                        

                            

                            

                        

                        

                            

                                
RBR-9wwstd Use of the PET-Scan examination in the evaluation of the treatment of patients diagnosed with Head and Neck Cancer


                                Date of registration:
                                
                                    11/24/2017                                    (mm/dd/yyyy)
                                
                                

                                Last approval date :
                                
                                    11/24/2017                                    (mm/dd/yyyy)
                                
                                
Study type:


                                
Interventional


                                
 


                                
 


                                
Scientific title:


                                

                                                                        

                                        
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Use of 18FDG-PET-CT as a predictor of efficacy for locoregional control and survival in the treatment of Head and Neck Squamous-Cell Carcinoma

                                        

                                        
pt-br

                                        
Uso do 18FDG-PET-CT como preditor de eficácia para controle locorregional e sobrevida em Carcinoma Epidermóide de Cabeça e Pescoço

                                        
                                


                                
 



                                
Trial identification

                                
    
                                    
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                                        UTN code: 
                                        U1111-1204-7946
                                    
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    Public title:
    
                                        
    
                                                                                        
    
                                                    
    en
    
                                                    
    Use of the PET-Scan examination in the evaluation of the treatment of patients diagnosed with Head and Neck Cancer
    
                                                
    
                                                    
    pt-br
    
                                                    
    Uso do exame de PET- Scan na avaliação do tratamento de pacientes com diagnóstico de Câncer de Cabeça e Pescoço
    
                                                
                                            
    
                                    
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    Scientific acronym:
    
                                        
    
                                                                                                                                
    
                                    
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    Public acronym:
    
                                        
    
                                                                                                                                
    
                                    
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                                        Secondaries identifiers:
                                                                                                                            
      
                                                
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                                                    N°: 1288/09
      
                                                    Issuing authority:
                                                    Comitê de Ètica em Pesquisa Hospital AC Camargo 
                                                
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                                                    N°: 0109.0.022.000-09-CAAE
      
                                                    Issuing authority:
                                                    Sisnep
                                                
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Sponsors

                                
    
                                    
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                                        Primary sponsor:
                                        AC Camargo Cancer Center
                                    
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                                        Secondary sponsor:
                                                                                                                                                                                                            
      
                                                
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                                                    Institution:
                                                    AC Camargo Cancer Center
                                                
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                                        Supporting source:
                                                                                                                            
      
                                                
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                                                    Institution:
                                                    AC Camargo Cancer Center
                                                
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Health conditions

                                
    
                                    
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    Health conditions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Scamous Cell- Carcinoma of Head and Neck
Neoplasms
Positron Emission Tomography Computed Tomography
    
                                                
    
                                                
    pt-br
    
                                                
    Carcinoma de Células Escamosas
Neoplasias 
Tomografia Computadorizada com Emissão de Positron
    
                                                
                                            
    
                                    
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    General descriptors for health conditions:
    
                                                                                
    
                                                
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                                                    C04
                                                    Neoplasms
                                                
    
                                                
    
                                                
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                                                    C04
                                                    Neoplasias
                                                
    
                                                
    
                                                
    es
    
                                                
    
                                                    C04
                                                    Neoplasias
                                                
    
                                                
                                            
     
    
                                    
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    Specific descriptors:
    
                                                                                
     
    
                                    
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Interventions

                                
    








                                    
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    Interventions:
    
                                        
    
                                                                                        
    
                                                
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    Study of a single experimental arm, without control group (uncontrolled study), 49 recruited patients undergoing induction chemotherapy for Squamous- Cell Carcinoma of Head and Neck, in which experimental character of the study is based on early  the metabolic evaluation of response to treatment, comparing the uptake of 18 FDG-PET CT after one cycle of chemotherapy (14 days after cycle 1-early evaluation) with the usual morphological method of exclusive computed tomography after the second cycle of chemotherapy. Patients responsive to therapy after cycle 2 received chemotherapy and radiotherapy according to standard therapy employed in the clinical practice.
    
                                                
    
                                                
    pt-br
    
                                                
    Estudo de um único braço experimental,sem grupo controle (estudo não controlado), 49 pacientes recrutados submetidos a quimioterapia de indução para Carcinoma Espinocelular de Cabeça e Pescoço, cujo carater experimental do estudo se baseia na avaliação metabólica de resposta ao tratamento, comparando a captação do 18 FDG-PET CT após um ciclo de quimioterapia (14 dias após ciclo 1-avaliação precoce) com o método morfológico habitual de tomografia exclusiva após o segundo ciclo de quimioterapia. Pacientes responsivos à terapia após ciclo 2 receberam quimioterapia e radioterapia de acordo com terapia habitualmente empregada. 
    
                                                
                                            
    
                                    
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    Descriptors:
    
                                        
    
                                                    
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                                                        E01.370.350.350.800.700.500
                                                        Positron Emission Tomography Computed Tomography
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        E01.370.350.350.800.700.500
                                                        Tomografia Computadorizada com Tomografia por Emissão de Pósitrons
                                                    
    
                                                    
    
                                                    
    es
    
                                                    
    
                                                        E01.370.350.350.800.700.500
                                                        Tomografía Computarizada por Tomografía de Emisión de Positrones
                                                    
    
                                                    
                                            
     
    
                                    
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Recruitment

                                
    
                                    
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                                        Study status:
                                                                                Recruitment completed
                                    
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                                        Countries
                                        
      
                                            
    • Brazil
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                                        Date first enrollment:
                                        
                                                                                        02/20/2010                                            (mm/dd/yyyy)
                                        

                                    
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                                                Target sample size:
                                                Gender:
                                                Minimum age:
                                                Maximum age:
                                            
    
                                            
    
                                                49
                                                -
                                                18 Y
                                                85 Y
                                            
    
                                            
    
                                    
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    Inclusion criteria:
    
                                        
    
                                                                                        
    
                                                
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    Patients diagnosed with locally advanced squamous cell carcinoma of the head and neck; Clinical Stages III, IVa and IVb;
Patients with primary tumors of oral cavity, oropharynx, larynx and hypopharynx;
Patients candidates for curative therapy with induction chemotherapy with the use of 03 drugs (taxanes, platinum and fluoropyrimidine) followed by radiotherapy associated with chemotherapy;
    
                                                
    
                                                
    pt-br
    
                                                
    Pacientes diagnosticados com carcinoma espinocelular localmente avançado de cabeça e pescoço; Estádios Clínicos III, IVa e IVb;
Pacientes com tumores primários de cavidade oral, orofaringe, laringe e hipofaringe;
Pacientes candidatos a terapia com intuito curativo com quimioterapia de indução com uso de 03 drogas (taxanes, platina e fluoropirimidina) seguido de radioterapia associado a qumioterapia;
    
                                                
                                            
    
                                    
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    Exclusion criteria:
    
                                        
    
                                                                                        
    
                                                
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    Heart disease active or not compensated by treatment, or acute myocardial infarction in the previous 6 months.
Active infection present (at the discretion of the investigator); Concomitant systemic diseases considered serious by the investigator; Another primary neoplasm (except in situ carcinoma of the uterine cervix or adequately treated basal cell carcinoma of the skin); Presence of severe psychiatric illness;
Participation in another experimental drug protocol;
    
                                                
    
                                                
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    Doença cardíaca ativa ou não compensada por tratamento, ou infarto agudo do miocárdio nos 6 meses prévios; Infecção ativa presente (ao critério do investigador); Doenças sistêmicas concomitantes consideradas sérias pelo investigador; Outra neoplasia primária (exceto carcinoma in situ da cérvix uterina ou carcinoma basocelular de pele adequadamente tratado);Presença de doença psiquiátrica severa;
Participação em outro protocolo com droga experimental

    
                                                
                                            
    
                                    
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Study type

                                
    
                                    
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    Study design:
    
                                        
    
                                                                                    
    
                                    
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                                                    Expanded access program
                                                    Purpose
                                                    Intervention assignment
                                                    Number of arms
                                                    Masking type
                                                    Allocation
                                                    Study phase
                                                
    
                                                
                                            
                                            
    
                                                
                                                Treatment
                                                Single-group
                                                1
                                                Double-blind
                                                Single-arm-study
                                                N/A
                                            
    
                                                
                                        
    
                                    
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Outcomes

                                
    
                                    
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    Primary outcomes:
    
                                        
    
                                                    
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                                                        primary outcome -To  determine the  efficacy  of the  treatment by  correlating the variation of the maximum SUV in the primary tumor and in the cervical lymph nodes registered before the treatment and after the cycle 1 (fourteenth day) with the end points tumor recurrence or death (whichever occurs first) . The Kaplan-Meier method was used to estimate survival data and long-rank tests were used to compare disease-free and overall survival  between the different groups observed (according to decrease  or increase of SUV after treatment at the fourteenth day). Calculations of time-free of tumor recurrence or death were considered from the first day of the first cycle of induction chemotherapy and the occurrence of tumor recurrence or death, respectively.

                                                    
    
                                                    
    
                                                    
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                                                        desfecho primário- determinar eficácia no tratamento em curso correlacinando a variação do SUV máximo no tumor primário e nos linfonodos cervicais, registrados antes do tratamento e após o ciclo 1 (décimo quarto dia) com os desfechos recidiva tumoral ou óbito (aquele que ocorrer primeiro). O Método de Kaplan-Meier foi utilizado para estimar os dados de sobrevida e testes de long-rank foram usados para comparar desempenho de sobrevida entre os diferentes grupos observados (de acordo com queda ou elevação de SUV após tratamento ao décimo quarto dia). Os cálculos do tempo livre de recidiva tumoral ou óbito foram considerados a partir do primeiro dia do primeiro ciclo de quimioterapia de indução e a ocorrência de recidiva tumoral ou óbito, respectivamente.

                                                    
    
                                                    
                                            
     
    
                                    
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    Secondary outcomes:
    
                                        
    
                                                
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                                                    secondary outcome- determine the overall survival of patients according to the maximum SUV variation in the primary tumor and cervical lymph nodes with the outcome of death (related cancer or non-cancer related)
                                                
    
                                                
    
                                                
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                                                    desfecho secundário- determinar sobrevida global dos pacientes correlacionando a variação do SUV máximo no tumor primário e nos linfonodos cervicais com o desfecho óbito (câncer relacionado ou não-câncer relacionado)
                                                
    
                                                
                                            
     
    
                                    
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Contacts

                                
    

                                    
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                                        Public contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Ulisses Ribaldo Nicolau
                                                
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                                                            Address:
                                                            Rua Professor Antônio Prudentre, 211, Liberdade
                                                        
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                                                            City: 
                                                            São Paulo / Brazil
                                                        
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                                                            Zip code:
                                                            01509-010
                                                        
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                                                    Phone:
                                                    +55(11)21895000
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    AC Camargo Cancer Center
                                                
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                                        Scientific contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Ulisses Ribaldo Nicolau
                                                
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                                                            Address:
                                                            Alameda Franca, 114, apto 73
                                                        
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                                                            City:
                                                            São Paulo / Brazil
                                                        
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                                                            Zip code:
                                                            01422-000
                                                        
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                                                    Phone:
                                                    +55(11)999011147
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    AC Camargo Cancer Center
                                                
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                                        Site contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Ulisses Ribaldo Nicolau
                                                
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                                                            Address:
                                                            Rua Professor Antônio Prudentre, 211, Liberdade
                                                        
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                                                            City:
                                                            São Paulo / Brazil
                                                        
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                                                            Zip code:
                                                            01509-010
                                                        
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                                                    Phone:
                                                    +55(11)21895000
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    AC Camargo Cancer Center
                                                
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Additional links:

                                                                
                            

                        

                    

                    
 

                            

        

        
 

        
    




            
    

    

        


Total de Ensaios Clínicos 16828.



Existem 8278 ensaios clínicos registrados.



Existem 4651 ensaios clínicos recrutando.



Existem 308 ensaios clínicos em análise.



Existem 5716 ensaios clínicos em rascunho.







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