PET/CT Scan-Guided Watchful Waiting or Neck Dissection of Locally Advanced Lymph Node Metastases in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Primary Head And Neck Cancer
A Multi-centre Randomised Phase III Trial Comparing PET-CT Guided Watch and Wait Policy Versus Planned Neck Dissection for the Management of Locally Advanced (N2/N3) Nodal Metastases in Patients With Head and Neck Squamous Cancer
RATIONALE: Imaging procedures, such as PET/CT scan, produce pictures of areas inside the body and may help doctors detect residual disease and plan the best treatment. Neck dissection is surgery to remove lymph nodes and other tissues in the neck. It is not yet known whether a neck dissection should always be performed in treating patients with head and neck cancer.
PURPOSE: This randomized phase III trial is studying PET/CT scan-guided watchful waiting compared with neck dissection of locally advanced lymph node metastases in treating patients who are undergoing chemotherapy and radiation therapy for primary head and neck cancer.
Visão geral do estudo
Status
Condições
Descrição detalhada
OBJECTIVES:
- To compare the efficacy, in terms of overall survival, disease-specific survival, recurrence, quality of life, and cost-effectiveness, of a PET/CT scan-guided watch and wait policy with the current practice of planned neck dissection in the management of advanced (N2 or N3) nodal metastases in patients with primary head and neck squamous cell carcinoma undergoing chemoradiotherapy.
- To assess the predictive value of PET/CT scanning in detecting persistent or residual disease in the primary site.
OUTLINE: This is a multicenter study. Patients are stratified according to center, chemotherapy schedule (concurrent platinum vs concurrent cetuximab vs neoadjuvant and concurrent platinum vs neoadjuvant docetaxel, platinum, and fluorouracil with concurrent platinum), T stage (T1-T2 vs T3-T4), and N stage (N2a-N2b vs N2c-N3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive standard concurrent chemoradiotherapy (CRT). Patients undergo PET/CT scan at 9-13 weeks after completion of CRT. Patients with complete response of primary site undergo neck dissection within 4 weeks.
- Arm II: Patients undergo neck dissection and then receive standard CRT. Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.
Patients are assessed periodically for quality-of-life. Tissue and blood samples collected periodically are stored for future research.
After completion of study treatment, patients are followed monthly for 1 year and then bimonthly for 1 year.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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England
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Coventry, England, Reino Unido, CV4 7AL
- Recrutamento
- Warwick Medical School Clinical Trials Unit
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Contato:
- Hisham Mehanna, MD
- Número de telefone: 44-247-696-5606
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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 confirmed head and neck squamous cell carcinoma (HNSCC), including any of the following subtypes:
- Oropharyngeal
- Laryngeal
- Oral
- Hypopharyngeal
- No primary nasopharyngeal carcinoma
Must have clinical and CT/MRI evidence of nodal metastases staged N2 (a, b, or c) or N3
- No occult nodal metastasis (i.e., large nodal metastasis but no proven primary site on clinical assessment)
- No N1 nodal metastasis
Planning to receive curative radical concurrent chemoradiotherapy (approved by study) for primary disease
- Patients undergoing neoadjuvant chemotherapy followed by concurrent chemoradiotherapy are eligible
- Able to undergo neck dissection surgery
- No current resection for primary tumor planned (e.g., resection of tonsil or base of tongue with flap reconstruction [diagnostic tonsillectomy allowed])
- No distant metastases to chest, liver, bones, or other sites
PATIENT CHARACTERISTICS:
- Not pregnant
- No other cancer diagnosis within the past 5 years except basal cell carcinoma or cervical carcinoma in situ
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior treatment for HNSCC
- No concurrent neoadjuvant chemoradiotherapy without concurrent chemotherapy
- No concurrent adjuvant chemotherapy
- No concurrent chemoradiotherapy for palliative purposes
- No concurrent radiotherapy alone
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Arm I
Patients receive standard concurrent chemoradiotherapy (CRT).
Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.
Patients with complete response of primary site undergo neck dissection within 4 weeks.
|
Patients undergo PET/CT scan
Patients undergo neck dissection
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Comparador Ativo: Arm II
Patients undergo neck dissection and receive standard concurrent CRT.
Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.
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Patients undergo PET/CT scan
Patients undergo neck dissection
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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Sobrevida global em 2 anos
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Health economics using quality adjusted life years
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Medidas de resultados secundários
Medida de resultado |
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Qualidade de vida
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Taxas de complicação
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Sobrevida específica da doença
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Recurrence and local control in neck
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Utility cost
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Accuracy of PET-CT scanning for assessing primary tumor
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hisham Mehanna, MD, Warwick Medical School
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
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 (Estimativa)
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 lábio e cavidade oral
- Carcinoma verrucoso estágio III da cavidade oral
- Carcinoma espinocelular estágio III de orofaringe
- Carcinoma espinocelular estágio III de hipofaringe
- Carcinoma espinocelular estágio III da laringe
- Carcinoma verrucoso estágio III da laringe
- carcinoma espinocelular estágio I de lábio e cavidade oral
- Carcinoma espinocelular estágio II de lábio e cavidade oral
- carcinoma espinocelular estágio I da hipofaringe
- carcinoma de células escamosas estágio I da laringe
- Carcinoma espinocelular estágio I de orofaringe
- Carcinoma espinocelular estágio II da hipofaringe
- Carcinoma espinocelular estágio II da laringe
- Carcinoma espinocelular estágio II de orofaringe
- câncer de língua
- Carcinoma verrucoso estágio I da cavidade oral
- Carcinoma verrucoso estágio II da cavidade oral
- Carcinoma verrucoso estágio I da laringe
- Carcinoma verrucoso estágio II da laringe
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CDR0000597895
- WMS-PET-NECK
- ISRCTN13735240
- EU-20856
- MREC-07/Q1604/35
- UKCRN ID: 3799
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