Medium Choroidal Melanoma: Enucleation vs. Iodine-125 Episcleral Plaque Irradiation
Collecte de données
Mélanome uvéal+14
+ Néoplasmes de la choroïde
+ Maladies oculaires
Étude thérapeutique
Résumé
Date de début de l'étude : 1 novembre 1986
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 21 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.