Phase I/II Study of High Dose Limited Volume Postoperative Reirradiation in Recurrent or Second Primary Carcinoma of the Head and Neck
radiation therapy
Carcinoma+5
+ Carcinoma de Células Escamosas
+ Neoplasias
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 2000
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the survival and local control in previously irradiated patients at high risk for local failure following regional resection of recurrent or second primary head and neck cancer. Determine the acute and late toxicities of this treatment in these patients. Determine the pattern of disease failure in these patients on this treatment. Determine any change in quality of life in these patients on this treatment. OUTLINE: Patients receive fractionated doses of radiotherapy five times weekly for 6 weeks. Quality of life is assessed prior to study, 2 months after radiotherapy, every 3 months for remainder of year 1, every 4 months for years 2-3, every 6 months for years 4-5, and then annually thereafter. Patients are followed 2 months after radiotherapy, every 3 months for year 1, every 4 months for year 2, every 6 months for years 3-5, and then annually thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 5 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the mucosa, recurrent (primary and/or nodal), or a second primary (positive or negative nodal), of one of the following: Oral cavity Oropharynx Hypopharynx Larynx Paranasal sinus Neck disease of unknown origin No distant metastases No primary in the nasopharynx Must have complete gross resection of disease Must have positive final margins, soft tissue extension of primary, positive extracapsular extension of lymph node disease, or at least 4 positive nodes without extracapsular extension Reirradiation field must overlap the previous field for a minimum of 3 cm in height, width, and length At least 6 months since prior radiotherapy with an overlap volume of at least 45 Gy No grade 3 or 4 toxicity for the following organ tissues: RTOG grade 3 or 4 skin, subcutaneous tissue, larynx, joint, or RTOG grade 4 mucous membrane or bone from prior radiotherapy Radiotherapy must begin within 6-12 weeks of surgery Prior radiotherapy records must be available PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant No history of invasive malignancy that would be expected to cause death within 3 years PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 3 ubicaciones
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, United StatesAbrir University of Alabama at Birmingham Comprehensive Cancer Center en Google MapsLoma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, United StatesVeterans Affairs Medical Center - Tampa (Haley)
Tampa, United States