- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00934518
Image Guided Intensity Modulated Reirradiation (IG-IMRT) With Cetuximab for Locoregionally Confined Recurrent Head and Neck Squamous Cell Carcinoma
Image Guided Intensity Modulated Reirradiation With Concurrent Cetuximab in the Treatment of Locoregionally Confined Relapsed Squamous Cell Carcinoma of the Head and Neck
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Hershey Cancer Institute
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients must have a pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer in the upper aerodigestive tract or a second squamous cell primary. Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥6 months following the end of the prior RT.
- The recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence).
- The majority (≥75%) of the tumor volume must have been in areas previously irradiated to ≥45 Gy. The previous irradiation must not exceed a maximum of 75 Gy.
- Patients must be at least 6 months from prior radiation therapy.
- If a resection is performed after the diagnosis of recurrence and before enrollment, either microscopic or macroscopic disease must be present (i.e. positive margins or gross residual).
- Karnofsky Performance Status 60-100.
- Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, bilirubin ≤ 1.5 mg/dl, creatinine ≤ 1.5 mg/dl, within 6 weeks prior to registration.
- Must be able to submit previous radiation records (simulation and portal film if available) in order to assure that cord tolerance is not exceeded.
- Patients must sign a study-specific informed consent form prior to study entry.
- The patient must be between the ages of 18 and 75.
Exclusion Criteria:
- Distant metastases.
- Completely resected recurrence with negative margins.
- Other concurrent invasive malignancies.
- Prior invasive malignancy unless disease free for at least two years (prior in situ malignancies are permissible).
- Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
- Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
- Previous treatment with cetuximab.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Radiation and Cetuximab
Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week Cetuximab 400 mg/m2 of body surface area over a period of 120 minutes day 1 250 mg/m2 of body surface area over a period of 60 minutes weekly during radiation |
Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week
Radiation Therapy 60 Gy total dose in 30 fractions: 2.0 Gy/fraction once daily five fractions per week Cetuximab 400 mg/m2 of body surface area over a period of 120 minutes day 1 250 mg/m2 of body surface area over a period of 60 minutes weekly during radiation |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
To estimate the incidence rate of acute and late toxicities associated with combined cetuximab and image guided intensity modulated reirradiation in patients with recurrent squamous cell cancer of the head and neck.
Periodo de tiempo: 5 years
|
5 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
To estimate the median and one-year, disease-free, and overall survival rates of the treated patients.
Periodo de tiempo: 5 years
|
5 years
|
To determine the pattern of disease progression in treated patients.
Periodo de tiempo: 5 years
|
5 years
|
To identify the impact of cetuximab and image guided intensity modulated reirradiation on patients' quality of life.
Periodo de tiempo: 5 years
|
5 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Heath B Mackley, MD, Penn State Hershey Cancer Institute
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PSHCI 08-066
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. .