- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00757549
3'-Deoxy-3'-[18F] Fluorothymidine and Fludeoxyglucose F 18 PET Scans in Evaluating Response to Cetuximab, Cisplatin, and Radiation Therapy in Patients With Advanced Cancer of the Oropharynx, Larynx, or Hypopharynx
Comparison of FLT and FDG PET in the Evaluation of Response to Cetuximab, Cisplatin and Radiation Therapy in Advanced Head and Neck Malignancies or Response to Standard Chemo-radiotherapy in Esophageal Malignancies
RATIONALE: Diagnostic procedures, such as 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fludeoxyglucose F 18 (FDG) PET scans, may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This pilot trial is studying FLT and FDG PET scans to see how well they evaluate response to cetuximab, cisplatin, and radiation therapy in patients with advanced cancer of the oropharynx, larynx, or hypopharynx.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
- Radiação: radioterapia
- Outro: análise laboratorial de biomarcadores
- Medicamento: cisplatina
- Radiação: fludesoxiglicose F 18
- Outro: método de coloração imuno-histoquímica
- Biológico: cetuximabe
- Genético: Ensaio de rotulagem de extremidade de entalhe dUTP mediado por TdT
- Outro: 3'-desoxi-3'-[18F]fluorotimidina
Descrição detalhada
OBJECTIVES:
Primary
- To assess whether 3'-deoxy-3'-[18F] fluorothymidine (FLT) and fludeoxyglucose F 18 (FDG) PET scans can be used to identify patients with advanced squamous cell carcinoma of the oropharynx, larynx, or hypopharynx who have a biochemical response after 2 weeks of induction therapy with cetuximab.
- To assess whether FLT and FDG PET imaging-based response after 20-30 Gy of radiotherapy is predictive of disease control at 6 months after completion of therapy.
Secondary
- To assess whether FLT and FDG PET imaging-based response after cetuximab therapy and/or 20-30 Gy of radiotherapy is predictive of pathologic complete response in these patients.
- To assess whether FLT and FDG PET imaging-based response after cetuximab therapy and/or 20-30 Gy of radiotherapy is predictive of disease-free survival at 2 years in these patients.
- To correlate suppression of FLT uptake after cetuximab therapy with thymidine kinase 1 activity and/or expression, proliferation, microvessel density, apoptosis, and signaling pathway analyses.
- To correlate suppression of FDG uptake after cetuximab therapy with expression of hexokinases, glucose transporter proliferation, microvessel density, apoptosis, and signaling pathway analyses.
- To test and refine the ability of a novel commercial software package to quantify treatment-induced structural and functional/molecular volumetric and sub-volumetric change.
- To develop a working method for expressing change and predicting outcome.
OUTLINE: Patients receive cetuximab IV on days 1 and 8 of course 1. Beginning in course 2 and all subsequent courses, patients receive cetuximab IV and cisplatin IV over 2 hours on day 1 and undergo radiotherapy once daily 5 days a week for 7 weeks. Treatment repeats every 7 days for a total of 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo 3'-deoxy-3'-[18F] fluorothymidine and fludeoxyglucose F 18 (FDG) PET scans at baseline, after the second dose of cetuximab, after 20-30 Gy of radiotherapy, and then at 6 weeks and 6 months after completion of radiotherapy.
Patients undergo tumor tissue biopsies at baseline and after the first dose of cetuximab for correlative laboratory studies. Samples are analyzed for proliferation (Ki-67 labeling index), microvessel density (CD-31 staining), apoptosis (TUNEL assay and caspase-3 by IHC) signaling pathway (expression of EGFR, AKT, and MAPK by IHC), molecules affecting FDG uptake (expression of GLUT1, GLUT3, and hexokinase by IHC), and thymidine kinase 1 activity or expression.
After completion of study treatment, patients are followed every 3 months for up to 5 years.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase inicial 1
Contactos e Locais
Locais de estudo
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma of the oropharynx, larynx, or hypopharynx
- Advanced disease
- Requires chemoradiotherapy
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 16 weeks
- Weight loss ≤ 10% within the past 3 months
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 3 times ULN
- Hemoglobin ≥ 8 g/dL
- Creatinine clearance ≥ 40 mL/min
- No peripheral neuropathy ≥ grade 2
- No NYHA class III-IV heart disease
- No uncontrolled infection
- No poorly controlled diabetes that would limit the ability to obtain reliable fludeoxyglucose F 18 PET scan results
- No other severe underlying disease that, in the judgment of the investigator, would preclude study participation
PRIOR CONCURRENT THERAPY:
- More than 2 weeks since prior major surgery and recovered
- No prior radiotherapy to the planned treatment field
- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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Percent change in the standard uptake value levels calculated for the identified volumes of interest for FLT and FDG PET scans from baseline to after 2 weeks of cetuximab therapy and from baseline to after 20-30 Gy of radiotherapy
|
Medidas de resultados secundários
Medida de resultado |
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Quantified change values (after cetuximab therapy and after 20-30 Gy of radiotherapy) for the FLT and FDG PET scan-based topographic profiles created using the ImQuant software package
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- Carcinoma espinocelular estágio III de orofaringe
- Carcinoma espinocelular estágio IV de orofaringe
- Carcinoma espinocelular recorrente de orofaringe
- Carcinoma espinocelular estágio III de hipofaringe
- Carcinoma espinocelular de hipofaringe estágio IV
- carcinoma epidermóide recorrente de hipofaringe
- Carcinoma espinocelular estágio III da laringe
- Carcinoma espinocelular estágio IV da laringe
- carcinoma espinocelular recorrente da laringe
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MC057M (Outro identificador: Mayo Clinic Cancer Center)
- P30CA015083 (Concessão/Contrato do NIH dos EUA)
- 08-002166 (Outro identificador: Mayo Clinic IRB)
- NCI-2009-01193 (Identificador de registro: NCI CTRP)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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