Phase III Randomized Prospective Trial of Open Versus Minimally Invasive, Video-Assisted Resection of Pulmonary Metastases
surgical procedure
+ surgical procedure
Neoplasias+2
+ Procesos Neoplásicos
+ Procesos Patológicos
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: I. Compare the overall survival and failure free survival of patients with isolated pulmonary metastases treated with minimally invasive (video assisted) resection or open resection. II. Compare patterns of recurrence in these patients after these treatments, and determine what factors are predictive of recurrence. III. Describe and compare the complications and morbidity associated with minimally-invasive and open approaches to metastasectomy in these patients. IV. Test whether the patients undergoing video-assisted thoracic surgery will have a significantly better quality of life over a six month period than those undergoing an open resection. OUTLINE: This is a randomized study. Patients are stratified according to histology (sarcoma vs epithelial vs germ cell vs melanoma) and disease laterality. After spiral CT showing pulmonary nodules are amenable to video-assisted thoracic surgery (VATS) resection with curative intent, patients are randomized to undergo either open resection (thoracotomy, median sternotomy, or bilateral sternothoracotomy) (arm I) or minimally-invasive video-assisted resection (arm II). Patients with isolated recurrence in the chest should have the recurrence(s) resected if feasible. The original resection approach (open versus VATS) should be the preferred method for the second resection, but is not required. Quality of life is assessed prior to randomization and then at 30 days, 3 months, and 6 months. Patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: There will be 530 patients accrued into this study in approximately 3 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 530 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 confirmed pulmonary metastases (unilateral or bilateral) identified by spiral CT scan No primary lung cancer Documented previous cancer with no history of prior metastasectomy Primary tumor must be definitively controlled No evidence of primary tumor recurrence, either locally or systemically No extrapulmonary metastatic disease or evidence of mediastinal lymph node involvement Lymph nodes greater than 1.0 cm on CT scan must be proven to be benign by tissue biopsy (mediastinoscopy) All lesions must be amenable to minimally invasive resection Must be amenable to video-assisted thoracic surgery with curative intent (complete removal of all documented lesions) No greater than 4 lesions PATIENT CHARACTERISTICS: Age: Over 18 Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: See Disease Characteristics PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
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 45 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 StatesVeterans Affairs Medical Center - San Francisco
San Francisco, United StatesCCOP - Christiana Care Health Services
Wilmington, United States