Abstract :
Purpoe: To decribe the baeline characteritic and tatu of patient enrolled in the Collaborative Ocular Melanoma tudy (COM) randomized clinical trial of pre-enucleation radiation of large choroidal melanoma conducted in the United tate and Canada, and to compare characteritic of patient enrolled with thoe of patient with tumor of eligible ize who were not enrolled in order to ae the generalizability of finding from the clinical trial.
Method: For all patient evaluated for the clinical trial at COM center from November 1986 through December 15, 1994, elected data were tranmitted to the COM Coordinating Center. For patient who enrolled in the clinical trial, ophthalmic and medical hitory, examination finding, and viual acuity meaurement were recorded prior to enrollment. tandardized A-can and contact B-can echographic examination were performed prior to enrollment, and photoechogram were ubmitted for central review for conitency with the diagnoi, independent meaurement of the apical height of the tumor, and decription of tumor configuration and internal reflectivity for each patient enrolled. Until January 1992, wide-angle fundu photograph and fluorecein angiogram taken prior to enrollment alo were ubmitted for central review to confirm conitency with the diagnoi. All data were integrated and analyzed at the COM Coordinating Center.
Reult: Of 6,078 patient with choroidal melanoma evaluated in COM center, 1,860 had tumor of eligible ize; of thee, 1,302 (70%) were eligible for the clinical trial, and 1,003 (77% of eligible patient) enrolled. The two principal reaon for ineligibility were other primary cancer and predominantly ciliary body melanoma. Ineligible patient were older than eligible patient, had larger choroidal melanoma, and had poorer viual acuity at the time of evaluation for the COM (P < .01, Wilcoxon rank um tet). Patient eligible for the clinical trial had a mean age of 60 year; 56% were male; almot all (97%) were non-Hipanic white. Among eligible patient, mean tumor apical height wa 9.5 mm and mean longet baal diameter wa 17.2 mm. Eligible patient who enrolled in the trial were imilar to eligible patient who did not enroll with repect to mot factor conidered. Thoe who enrolled had longer tumor baal diameter and better viual acuity in the fellow eye, more often had their primary reidence in Canada, and le often had education beyond high chool than did eligible patient who did not enroll (P < .05, Wilcoxon rank um tet and χ2 tet, repectively).
Concluion: The COM clinical trial of pre-enucleation radiation wa deigned to yield internally valid treatment comparion through random treatment aignment at time of enrollment. Finding alo have high external validity becaue a majority (54%) of all patient with tumor of eligible ize, and a large majority (77%) of all eligible patient, were enrolled. Furthermore, patient characteritic are imilar to thoe of patient included in other evaluation of thi method of treating large choroidal melanoma. Thu, finding from thi clinical trial apply to all patient who have large choroidal melanoma and atify COM eligibility criteria.
