American Journal of Ophthalmology
Volume 125, Issue 6 , Pages 767-778 , June 1998

The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma I: characteristics of patients enrolled and not enrolled COMS report no. 9

  • Collaborative Ocular Melanoma Study Group

      Affiliations

    • Corresponding Author InformationReprint requests to Barbara S. Hawkins, PhD, COMS Coordinating Center, 550 N Broadway, 9th Fl, Baltimore, MD 21205-2010; fax: (410) 955-0569

,Accepted 4 March 1998.

References 

  1. Scotto J, Fraumeni FJ, Lee JAH. Melanomas of the eye and other noncutaneous sites (epidemiologic aspects). J Natl Cancer Inst. 1976;56:489–491
  2. Manschot WA, van Peperzeel HA. Choroidal melanoma: enucleation or observation? A new approach. Arch Ophthalmol. 1980;98:71–77
  3. Lommatzsch P, Dietrich B. The effect of orbital irradiation on the survival rate of patients with choroidal melanoma. Ophthalmologica. 1976;173:49–52
  4. Char DH, Phillips TL. The potential for adjuvant radiotherapy in choroidal melanoma. Arch Ophthalmol. 1982;100:247–248
  5. Char DH, Phillips TL. Pre-enucleation irradiation of uveal melanoma. Br J Ophthalmol. 1985;69:177–179
  6. Collaborative Ocular Melanoma Study Research Group Straatsma BR, Fine SL, Earle JD, Hawkins BS, Diener-West M, McLaughlin JA. Enucleation versus plaque irradiation for choroidal melanoma. Ophthalmology. 1988;95:1000–1004
  7. Collaborative Ocular Melanoma Study Group . Design and methods of a clinical trial for a rare condition: the Collaborative Ocular Melanoma Study. COMS report no. 3. Controlled Clin Trials. 1993;14:362–391
  8. Collaborative Ocular Melanoma Study Group . Accuracy of diagnosis of choroidal melanomas in the Collaborative Ocular Melanoma Study. COMS report no. 1. Arch Ophthalmol. 1990;108:1268–1273
  9. Collaborative Ocular Melanoma Study Group. Complications of enucleation surgery: COMS report no. 2. In: Franklin RM, editor. Proceedings of the New Orleans Academy of Ophthalmology Symposium on Retina and Vitreous. New York: Kugler, 1993:181–190.
  10. Melia BM, Diener-West M. Modeling interrater agreement on an ordered categorical scale. In:  Lange N,  Ryan L,  Billard L,  Brillinger D,  Conquest L,  Greenhouse J editor. Case studies in biometry. New York: Wiley & Sons; 1994;p. 323–338
  11. Collaborative Ocular Melanoma Study Group . COMS manual of procedures. Accession no. PB95-179693. Springfield, Virginia: National Technical Information Service; 1995;
  12. Collaborative Ocular Melanoma Study Group . COMS forms book. Accession no. PB91-217315. Springfield, Virginia: National Technical Information Service; 1991;
  13. Bailey IL, Lovie JE. New design principles for visual acuity letter charts. Am J Optom Physiol Opt. 1976;53:740–745
  14. Ferris FL, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. Am J Ophthalmol. 1982;94:91–96
  15. Snedecor GW, Cochran WG. In: Statistical methods. 7th ed. Ames, Iowa: Iowa State University Press; 1980;p. 144–145
  16. Armitage P, Berry G. In: Statistical methods in medical research. 2nd ed. Boston, Massachusetts: Blackwell Scientific; 1987;p. 372–374
  17. Collaborative Ocular Melanoma Study Group Schachat AP, Markowitz JA, Hawkins BS, Fine SL. Nonocular cancers in patients with choroidal melanoma [letter]. Ophthalmology. 1990;97:837–838
  18. Egan KM, Seddon JM, Glynn RJ, Gragoudas ES, Albert DM. Epidemiologic aspects of uveal melanoma. Surv Ophthalmol. 1988;32:239–251
  19. Wells CG, Bradford RH, Fish GE, Straatsma BR, Hawkins BS for the COMS Group. Choroidal melanomas in American Indians. Arch Ophthalmol 1996;114:1017–1018.
  20. Diener-West M, Willis DM, Hawkins BS for the Collaborative Ocular Melanoma Study Group. Sociodemographic factors of patient participation in randomized trials: findings from the COMS. ARVO abstracts. Invest Ophthalmol Vis Sci 1991;32(4,suppl):980.
  21. Diener-West M, Hawkins BS, Willis DM. Sociodemographic characteristics associated with patient enrollment in the Collaborative Ocular Melanoma Study [abstract]. Controlled Clin Trials. 1991;12:657
  22. Karnofsky DA, Abelmann WH, Craver LF, Burchenal JH. The use of nitrogen mustards in the palliative treatment of carcinoma. Cancer. 1948;1:634–656
  23. Hawkins BS for the Collaborative Ocular Melanoma Study Group. Defining the universe of patients [abstract]. Controlled Clin Trials 1989;10:324.
  24. Augsburger JJ, Lauritzen K, Gamel JW, Lowry JC, Brady LW. Matched group study of preenucleation radiotherapy versus enucleation alone for primary malignant melanoma of the choroid and ciliary body. Am J Clin Oncol. 1990;13:382–387
  25. Char DH, Phillips TL, Andejeski Y, Crawford JB, Kroll S. Failure of preenucleation radiation to decrease uveal melanoma mortality. Am J Ophthalmol. 1988;106:21–26
  26. Luyten GPM, Mooy CM, Eijkenboom WMH, et al.  No demonstrated effect of pre-enucleation irradiation on survival of patients with uveal melanoma. Am J Ophthalmol. 1995;119:786–791
  27. Collaborative Ocular Melanoma Study Group . The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma, II: initial mortality findings. COMS report no. 10. Am J Ophthalmol. 1998;125:779–796

☆ The COMS has received support from the National Eye Institute and the National Cancer Institute through cooperative agreements EY06253, EY06257, EY06258, EY06259, EY06260, EY06264, EY06265, EY06266, EY06268, EY06269, EY06270, EY06274, EY06275, EY06276, EY06279, EY06280, EY06282, EY06283, EY06284, EY06287, EY06288, EY06289, EY06291, EY06839, EY06843, EY06844, EY06848, EY06858, and EY06899 with the National Institutes of Health, Bethesda, Maryland.

PII: S0002-9394(98)00038-5

American Journal of Ophthalmology
Volume 125, Issue 6 , Pages 767-778 , June 1998

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