OCULAR MELANOMA

本研究是一项多中心、随机、对照临床试验

The proposed study is a multicenter, randomized, controlled clinical trial designed to compare enucleation of eyes with choroidal melanomas with irradiation on the basis of survival after diagnosis and treatment. Candidates for the study will be newly diagnosed cases with choroidal melanoma in one eye greater than 3 mm in height and up to 18 mm by 8 mm in size and with no evidence of metastatic disease who are 21 years of age or older. Informed consent will be obtained from all patients prior to randomization. All patients will be followed for a minimum of ten years or until death. The outcome of primary interest is death from all causes. Secondary outcomes will include death from cancer, whether metastatic or not, and diagnosis of other tumors. Complications of irradiation and changes in visual acuity will be documented and monitored carefully throughout folow-up. The study will be conducted in clinical centers located throughout the United States which draw patients from the major population centers; a Coordinating Center; a Fundus Photograph Reading Center; a Pathology Center; and a Sonography Center. Each clinical center will be expected to enroll at least 12 eligible patients each year. The study will be directed by a Executive Committee consisting of 12 to 15 study investigators and a Steering Committee to deal with day-to-day operational decisions. An independent Data and Safety Monitoring Committee will be responsible for assuring the ethical conduct of the study and for reviewing the accumulating data on a regular basis for evidence of adverse or beneficial effects of therapy. The intention of the investigators is to collect and analyze data of high quality which will provide a conclusive answer to the question of therapeutic preference in the management of patients with choroidal melanomas. Standardized clinical and data collection procedures will be employed, and standarized forms will be used in all centers. Central training and certification of all study staff will be required.