Medium Choroidal Melanoma: Enucleation vs. Iodine-125 Episcleral Plaque Irradiation
Data Collection
Uveal Melanoma+14
+ Choroid Neoplasms
+ Eye Diseases
Treatment Study
Summary
Study start date: November 1, 1986
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.