Phase II Multi-Institutional Trial of Targeted Supradose Cisplatin Chemoradiation for Stage IV Squamous Cell Carcinoma of the Head and Neck
cisplatin
+ radiation therapy
Carcinoma+5
+ Carcinoma de Células Escamosas
+ Neoplasias
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 1997
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Determine the percentage of patients for whom a complete course of therapy can be administered using targeted supradose cisplatin chemoradiation in patients with squamous cell carcinoma of the head and neck. II. Determine the partial and complete response rate of cisplatin chemoradiation. III. Determine the incidence of adverse events using cisplatin chemoradiation therapy. IV. Determine the rate of disease-free survival and overall survival in these patients. V. Determine the incidence and pattern of recurrence in these patients. VI. Document quality of life measured by disease-specific instruments in these patients. OUTLINE: All patients receive four courses of cisplatin on days 1, 8, 15, and 22 concurrent with radiotherapy. One course of chemotherapy consists of intra-arterial cisplatin given over 3-5 minutes. Radiotherapy is given 5 days a week for 7 weeks. This weekly cisplatin chemoradiation course will be repeated 4 times, providing recovery from toxicity is present. Dexamethasone is started the evening prior to cisplatin treatment, and continues until the morning following the procedure. PROJECTED ACCRUAL: 60 patients will be enrolled.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 60 pacientes
Número total de participantes que el ensayo clínico espera reclutar.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 proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx No distant metastatic disease No previous or concurrent head and neck primaries No lip, nasopharynx, or salivary gland lesions No recurrent tumors Stage IV disease comprised of T4 NO-3 lesions PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky greater than 60 Life Expectancy: Not specified Hematopoietic: ANC greater than 2,000 Platelet count greater than 100,000 Hepatic: Not specified Renal: Creatinine clearance greater than 50 mL/min Cardiovascular: Not specified Other: Not pregnant or nursing No adverse medical illnesses No imaging studies performed greater than one month preregistration No laboratory studies greater than 2 weeks preregistration No other malignancies, except for basal or squamous cell of the skin, within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head and neck Surgery: No prior surgery to study site other than a biopsy Other: Protocol treatment must begin within 8 weeks of biopsy
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 13 ubicaciones
University of California San Diego Cancer Center
La Jolla, United StatesAbrir University of California San Diego Cancer Center en Google MapsUCSF Cancer Center and Cancer Research Institute
San Francisco, United StatesUniversity of Iowa Hospitals and Clinics
Iowa City, United StatesMBCCOP - LSU Medical Center
New Orleans, United States