Collaborative Ocular Melanoma Study (COMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2002 by National Eye Institute (NEI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Eye Institute (NEI)
ClinicalTrials.gov Identifier:
NCT00000124
First received: September 23, 1999
Last updated: June 1, 2006
Last verified: June 2002
  Purpose

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.


Condition Intervention Phase
Choroid Neoplasms
Uveitis
Procedure: Brachytherapy
Procedure: Eye Removal
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

Study Start Date: November 1986
Detailed Description:

For more than 100 years, removal of the eye (enucleation) has been the standard treatment for choroidal melanoma. Before the COMS was initiated in 1986, interest in radiation therapy had increased because of the potential for saving the eye and perhaps some vision. However, the merits of radiation with respect to prolonging patient survival were unknown. The best data from nonrandomized studies suggested that there was no difference in length of remaining life between patients treated with radiation and those whose eyes were enucleated. Thus, it was appropriate and necessary to conduct a randomized, controlled clinical trial in which a large number of patients would be followed for many years in order to compare enucleation and radiation with respect to relative success in prolonging survival of choroidal melanoma patients.

The Collaborative Ocular Melanoma Study (COMS) is a set of long-term, multicenter, randomized controlled trials. In the trial for patients with tumors of medium size, enucleation and irradiation with an iodine-125 episcleral plaque are compared on the basis of length of remaining life. All randomized patients will be followed for 5 to 15 years or until death. For patients randomly assigned to enucleation, the eye was removed following a standard procedure. For patients assigned to plaque irradiation, the margins of the tumor were located and the dimensions of the tumor were measured by the ophthalmic surgeon. A gold plaque with a plastic seed carrier that contained the proper dosage and configuration of radioactive iodine seeds was sutured to the outside (sclera) of the eye over the base of the tumor. This procedure made possible the delivery of a high dose of radiation to a very localized area (85 Gy [TG-43] to the tumor apex). The plaque typically was removed from the eye after three to seven days. Enrollment was completed in this trial in July 1998 with 1,317 patients enrolled. Clinical follow-up of patients will end in July 2003.

In the COMS trial of preoperative radiation, patients with large tumors were randomized to enucleation alone or to enucleation preceded by 20 Gy of external beam radiation. The two randomly assigned groups of patients were followed for at least five years or until death and have been compared on the basis of length of remaining life and other outcomes. Enrollment in this trial was completed in December 1994, with 1,003 patients enrolled. Clinical follow-up of all patients in this trial ended in July 2000.

Accrual to a nonrandomized pilot study to assess the feasibility of a randomized trial for small tumors was halted in 1989. Additional followup of those 204 patients was carried out from 1994 to 1996.

The COMS is conducted in 43 clinical centers located in major population areas of the United States and Canada. Six resource centers participate and have major roles in quality assurance for the study. Information gathered and analyzed includes time to death from all causes, time to death from cancer (whether metastatic choroidal melanoma or not), diagnosis of other tumors, complications of radiation, and changes in visual acuity. A parallel study of quality of life for patients enrolled in the trial of radioactive plaque was initiated in January 1995. From November 1986 through July 1998, 8,712 patients with choroidal melanoma of all sizes were screened for eligibility for a COMS clinical trial.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000124     History of Changes
Other Study ID Numbers: NEI-23
Study First Received: September 23, 1999
Last Updated: June 1, 2006
Health Authority: United States: Federal Government

Keywords provided by National Eye Institute (NEI):
Choroidal Melanoma
Ocular Melanoma

Additional relevant MeSH terms:
Neoplasms
Choroid Neoplasms
Uveitis
Chorioretinitis
Uveal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Choroid Diseases
Uveal Diseases
Retinitis
Retinal Diseases
Choroiditis
Uveitis, Posterior
Panuveitis

ClinicalTrials.gov processed this record on July 31, 2014