Collaborative Ocular Melanoma Study (COMS)

NCT00000124 | Unknown Phase 3

• 1 other identifier: NEI-23
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate therapeutic interventions for patients who have choroidal melanoma, the most common primary eye cancer affecting adults, and to assess the potential life-preserving as well as sight-preserving role of radiation therapy. To determine which of two standard treatments, removal of the eye or brachytherapy, is more likely to prolong survival of eligible patients with medium-sized choroidal melanoma. To determine whether preoperative radiation prolongs life for patients whose eyes with large choroidal melanoma are enucleated.

Conditions

Choroid Neoplasms; Uveitis

Keywords

Choroidal Melanoma; Ocular Melanoma

Interventions

Brachytherapy PROCEDURE

Eye Removal PROCEDURE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Related Publications (25)

• Byrne SF, Marsh MJ, Boldt HC, Green RL, Johnson RN, Wilson DJ. Consistency of observations from echograms made centrally in the Collaborative Ocular Melanoma Study COMS Report No. 13. Ophthalmic Epidemiol. 2002 Feb;9(1):11-27. doi: 10.1076/opep.9.1.11.1719.

  PMID: 11815892 BACKGROUND

• Collaborative Ocular Melanoma Study Group. Sociodemographic and clinical predictors of participation in two randomized trials: findings from the Collaborative Ocular Melanoma Study COMS report no. 7. Control Clin Trials. 2001 Oct;22(5):526-37. doi: 10.1016/s0197-2456(01)00157-x.

  PMID: 11578786 BACKGROUND

• Moy CS, Albert DM, Diener-West M, McCaffrey LD, Scully RE, Willson JK; Collaborative Ocular Melanoma Study Group, prepared by COMS Mortality Coding Committee. Cause-specific mortality coding. methods in the collaborative ocular melanoma study coms report no. 14. Control Clin Trials. 2001 Jun;22(3):248-62. doi: 10.1016/s0197-2456(01)00113-1.

  PMID: 11384789 BACKGROUND

• Collaborative Ocular Melanoma Study Group.. Assessment of metastatic disease status at death in 435 patients with large choroidal melanoma in the Collaborative Ocular Melanoma Study (COMS): COMS report no. 15. Arch Ophthalmol. 2001 May;119(5):670-6. doi: 10.1001/archopht.119.5.670.

  PMID: 11346394 BACKGROUND

• Melia BM, Abramson DH, Albert DM, Boldt HC, Earle JD, Hanson WF, Montague P, Moy CS, Schachat AP, Simpson ER, Straatsma BR, Vine AK, Weingeist TA; Collaborative Ocular Melanoma Study Group. Collaborative ocular melanoma study (COMS) randomized trial of I-125 brachytherapy for medium choroidal melanoma. I. Visual acuity after 3 years COMS report no. 16. Ophthalmology. 2001 Feb;108(2):348-66. doi: 10.1016/s0161-6420(00)00526-1.

  PMID: 11158813 BACKGROUND

• Echography (Ultrasound) Procedures for the Collaborative Ocular Melanoma Study (COMS), Report no. 12, Part II. J Ophthalmic Nurs Technol. 1999 Sep-Oct;18(5):219-32. No abstract available.

  PMID: 10847049 BACKGROUND

• Echography (ultrasound) procedures for the Collaborative Ocular Melanoma Study (COMS), Report no. 12, Part I. J Ophthalmic Nurs Technol. 1999 Jul-Aug;18(4):143-9. No abstract available.

  PMID: 10847038 BACKGROUND

• Quality of life assessment in the collaborative ocular melanoma study: design and methods. COMS-QOLS Report No. 1. COMS Quality of Life Study Group. Ophthalmic Epidemiol. 1999 Mar;6(1):5-17. doi: 10.1076/opep.6.1.5.1565.

  PMID: 10384680 BACKGROUND

• The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma III: local complications and observations following enucleation COMS report no. 11. Am J Ophthalmol. 1998 Sep;126(3):362-72. doi: 10.1016/s0002-9394(98)00091-9.

  PMID: 9744369 BACKGROUND

• 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 Jun;125(6):779-96. doi: 10.1016/s0002-9394(98)00039-7.

  PMID: 9645716 BACKGROUND

• 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. Am J Ophthalmol. 1998 Jun;125(6):767-78. doi: 10.1016/s0002-9394(98)00038-5.

  PMID: 9645715 BACKGROUND

• Histopathologic characteristics of uveal melanomas in eyes enucleated from the Collaborative Ocular Melanoma Study. COMS report no. 6. Am J Ophthalmol. 1998 Jun;125(6):745-66. doi: 10.1016/s0002-9394(98)00040-3.

  PMID: 9645714 BACKGROUND

• Factors predictive of growth and treatment of small choroidal melanoma: COMS Report No. 5. The Collaborative Ocular Melanoma Study Group. Arch Ophthalmol. 1997 Dec;115(12):1537-44. doi: 10.1001/archopht.1997.01100160707007.

  PMID: 9400787 BACKGROUND

• Grossniklaus HE, Albert DM, Green WR, Conway BP, Hovland KR. Clear cell differentiation in choroidal melanoma. COMS report no. 8. Collaborative Ocular Melanoma Study Group. Arch Ophthalmol. 1997 Jul;115(7):894-8. doi: 10.1001/archopht.1997.01100160064010.

  PMID: 9230830 BACKGROUND

• Mortality in patients with small choroidal melanoma. COMS report no. 4. The Collaborative Ocular Melanoma Study Group. Arch Ophthalmol. 1997 Jul;115(7):886-93.

  PMID: 9230829 BACKGROUND

• Wells CG, Bradford RH, Fish GE, Straatsma BR, Hawkins BS. Choroidal melanomas in American Indians. COMS Group. Collaborative Ocular Melanoma Study. Arch Ophthalmol. 1996 Aug;114(8):1017-8. doi: 10.1001/archopht.1996.01100140225024. No abstract available.

  PMID: 8694711 BACKGROUND

• Design and methods of a clinical trial for a rare condition: the Collaborative Ocular Melanoma Study. COMS Report No. 3. Control Clin Trials. 1993 Oct;14(5):362-91. doi: 10.1016/0197-2456(93)90052-f.

  PMID: 8222668 BACKGROUND

• Accuracy of diagnosis of choroidal melanomas in the Collaborative Ocular Melanoma Study. COMS report no. 1. Arch Ophthalmol. 1990 Sep;108(9):1268-73. doi: 10.1001/archopht.1990.01070110084030.

  PMID: 2205183 BACKGROUND

• Earle J, Kline RW, Robertson DM. Selection of iodine 125 for the Collaborative Ocular Melanoma Study. Arch Ophthalmol. 1987 Jun;105(6):763-4. doi: 10.1001/archopht.1987.01060060049030. No abstract available.

  PMID: 3579705 BACKGROUND

• Diener-West M, Earle JD, Fine SL, Hawkins BS, Moy CS, Reynolds SM, Schachat AP, Straatsma BR; Collaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, III: initial mortality findings. COMS Report No. 18. Arch Ophthalmol. 2001 Jul;119(7):969-82. doi: 10.1001/archopht.119.7.969.

  PMID: 11448319 BACKGROUND

• Diener-West M, Earle JD, Fine SL, Hawkins BS, Moy CS, Reynolds SM, Schachat AP, Straatsma BR; Collaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, II: characteristics of patients enrolled and not enrolled. COMS Report No. 17. Arch Ophthalmol. 2001 Jul;119(7):951-65. doi: 10.1001/archopht.119.7.951.

  PMID: 11448318 BACKGROUND

• Boldt HC, Melia BM, Liu JC, Reynolds SM; Collaborative Ocular Melanoma Study Group. I-125 brachytherapy for choroidal melanoma photographic and angiographic abnormalities: the Collaborative Ocular Melanoma Study: COMS Report No. 30. Ophthalmology. 2009 Jan;116(1):106-115.e1. doi: 10.1016/j.ophtha.2008.10.013.

  PMID: 19118701 DERIVED

• Fine SL, Hawkins BS. The investigators' perspective on the collaborative ocular melanoma study. Arch Ophthalmol. 2007 Jul;125(7):968-71. doi: 10.1001/archopht.125.7.968. No abstract available.

  PMID: 17620582 DERIVED

• Collaborative Ocular Melanoma Study Group. Incidence of cataract and outcomes after cataract surgery in the first 5 years after iodine 125 brachytherapy in the Collaborative Ocular Melanoma Study: COMS Report No. 27. Ophthalmology. 2007 Jul;114(7):1363-71. doi: 10.1016/j.ophtha.2006.10.039. Epub 2007 Mar 6.

  PMID: 17337065 DERIVED

• Collaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma: V. Twelve-year mortality rates and prognostic factors: COMS report No. 28. Arch Ophthalmol. 2006 Dec;124(12):1684-93. doi: 10.1001/archopht.124.12.1684.

  PMID: 17159027 DERIVED

MeSH Terms

Conditions

Choroid Neoplasms; Uveitis; Uveal Melanoma

Interventions

Brachytherapy; Eye Enucleation

Condition Hierarchy (Ancestors)

Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Neoplasms; Eye Diseases; Choroid Diseases; Uveal Diseases; Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 23, 1999
• First Posted: September 24, 1999
• Study Start: November 1, 1986
• Last Updated: June 2, 2006

Record last verified: 2002-06