A Phase II Study of 3-Dimensional Conformal Hyperfractionation Radiation Therapy (3D-CHRT) With Dose Escalation and Amifostine Mucosal Protection for Patients With Favorable Prognosis Inoperable Stage II-IIIA/B Non-Small Cell Lung Cancer (NSCLC) Receiving Paclitaxel and Carboplatin
carboplatin
+ paclitaxel
+ radiation therapy
Neoplasias bronquiales+7
+ Carcinoma broncogénico
+ Enfermedades del pulmón
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 2000
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the probability of overall survival and local control in patients with favorable prognosis, unresectable stage II-IIIA/B non-small cell lung cancer receiving paclitaxel and carboplatin plus 3-D conformal hyperfractionation radiotherapy (3D-CHRT). Determine the incidence and severity of nonhematologic toxicity, specifically esophagitis and pneumonitis, during 3D-CHRT and chemotherapy with paclitaxel and carboplatin in these patients. Correlate complication rate with radiation based on the effective dose to determine safe treatment guidelines. Determine the feasibility of patient-specific dose escalation using this regimen in these patients. Determine the quality of life and symptom distress in these patients on this regimen. OUTLINE: This is a dose-escalation study of 3-D conformal hyperfractionated radiotherapy (3D-CHRT). Patients receive paclitaxel IV over 1 hour followed immediately by carboplatin IV over 30 minutes weekly for 6-8 weeks. Patients undergo 3D-CHRT twice daily five days a week for 6-8 weeks. Cohorts of patients receive escalating doses of 3D-CHRT in 4 dose levels. Quality of life is assessed prior to study, weekly during chemotherapy and radiotherapy, and at 3 and 6 months. Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 3 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: Patients with unresected locally advanced non-small cell lung cancer Stage II, IIIA, or IIIB No evidence of hematogenous metastases No pleural effusion(s) on chest x-ray (except after a thoracotomy or other invasive thoracic procedure) No intrathoracic tumor recurrence following resection PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count at least 130,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 1.5 times upper limit of normal (unless caused by documented benign disease) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active or symptomatic cardiac disease No acute myocardial infarction within the past 6 months No angina No congestive heart failure No uncontrolled arrhythmias Cardiac ejection fraction greater than 50% Pulmonary: FEV1 at least 1.25 L AND DLCO at least 50% predicted Other: Not pregnant Fertile patients must use effective contraception Weight loss no greater than 5% within 3 months of diagnosis No other prior malignancy within the past 3 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic or neck radiotherapy 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 2 ubicaciones
Sylvester Cancer Center, University of Miami
Miami, United StatesAbrir Sylvester Cancer Center, University of Miami en Google MapsBaptist Hospital of Miami
Miami, United States