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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
England
-
Coventry, England, Reino Unido, CV4 7AL
- Reclutamiento
- Warwick Medical School Clinical Trials Unit
-
Contacto:
- Hisham Mehanna, MD
- Número de teléfono: 44-247-696-5606
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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
|
|
Comparador activo: Arm II
Patients undergo neck dissection and receive standard concurrent CRT.
Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.
|
Patients undergo PET/CT scan
Patients undergo neck dissection
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
|---|
|
Supervivencia global a los 2 años
|
|
Health economics using quality adjusted life years
|
Medidas de resultado secundarias
Medida de resultado |
|---|
|
Calidad de vida
|
|
Tasas de complicaciones
|
|
Supervivencia específica de la enfermedad
|
|
Recurrence and local control in neck
|
|
Utility cost
|
|
Accuracy of PET-CT scanning for assessing primary tumor
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hisham Mehanna, MD, Warwick Medical School
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Carcinoma de células escamosas de labio y cavidad oral en estadio III
- Carcinoma verrugoso de la cavidad oral en estadio III
- Carcinoma de células escamosas de orofaringe en estadio III
- Carcinoma epidermoide de hipofaringe en estadio III
- Carcinoma de células escamosas de laringe en estadio III
- Carcinoma verrucoso de laringe en estadio III
- Carcinoma epidermoide de labio y cavidad oral en estadio I
- Carcinoma de células escamosas de labio y cavidad oral en estadio II
- Carcinoma epidermoide de hipofaringe en estadio I
- Carcinoma de células escamosas de laringe en estadio I
- Carcinoma de células escamosas de orofaringe en estadio I
- Carcinoma de células escamosas de hipofaringe en estadio II
- Carcinoma de células escamosas de laringe en estadio II
- Carcinoma de células escamosas de la orofaringe en estadio II
- cáncer de lengua
- Carcinoma verrugoso de la cavidad oral en estadio I
- Carcinoma verrugoso de la cavidad oral en estadio II
- Carcinoma verrugoso de laringe en estadio I
- Carcinoma verrugoso de laringe en estadio II
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDR0000597895
- WMS-PET-NECK
- ISRCTN13735240
- EU-20856
- MREC-07/Q1604/35
- UKCRN ID: 3799
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .