Medium Choroidal Melanoma: Enucleation vs. Iodine-125 Episcleral Plaque Irradiation
Colección de datos
Melanoma uveal+11
+ Enfermedades Oculares
+ Neoplasias oculares
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 1986
Fecha en la que se inscribió al primer participante.For over a century, the standard treatment for choroidal melanoma, a type of eye cancer, has been the removal of the eye. However, interest in radiation therapy grew as it potentially allows patients to keep their eye and some vision. The Collaborative Ocular Melanoma Study (COMS), started in 1986, aims to compare the effectiveness of radiation therapy and eye removal in prolonging the life of patients with choroidal melanoma. This study is important as it could provide a new standard for treating this condition, potentially improving patients' quality of life and addressing current challenges. In the COMS study, patients with medium-sized tumors are randomly assigned to either eye removal or radiation therapy using an iodine-125 episcleral plaque. For those assigned to eye removal, the procedure follows a standard method. For those receiving radiation, a gold plaque containing radioactive iodine seeds is attached to the outside of the eye, delivering a high dose of radiation to the tumor. The plaque is typically removed after three to seven days. Enrollment for this trial ended in July 1998 with 1,317 patients. In another trial, patients with large tumors receive either eye removal or eye removal preceded by external beam radiation. Enrollment for this trial ended in December 1994 with 1,003 patients. The study is conducted across 43 clinical centers in the United States and Canada, and outcomes measured include time to death from all causes, time to death from cancer, diagnosis of other tumors, complications of radiation, and changes in visual acuity.
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 21 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
Men and women eligible for the study must be age 21 or older, have primary choroidal melanoma in only one eye, and have no evidence of metastatic disease. Accurate estimation of tumor thickness by echography must also be possible.