Status Unknown

Phase 3
Age: 21Years +
All Genders
ID00000124

Collaborative Ocular Melanoma Study (COMS)

Led by National Eye Institute (NEI) · Updated on 2006-06-02

N/A

Participants Needed

N/A

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Collaborative Ocular Melanoma Study (COMS)

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Site Locations not provided

Location information for this trial is currently unavailable.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

RANDOMIZED

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Consistency of observations from echograms made centrally in the Collaborative Ocular Melanoma Study COMS Report No. 13.

Sandra Frazier Byrne, Marta J Marsh, H Culver Boldt...

https://pubmed.ncbi.nlm.nih.gov/11815892

Sociodemographic and clinical predictors of participation in two randomized trials: findings from the Collaborative Ocular Melanoma Study COMS report no. 7.

Collaborative Ocular Melanoma Study Group

https://pubmed.ncbi.nlm.nih.gov/11578786

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.

Collaborative Ocular Melanoma Study Group.

https://pubmed.ncbi.nlm.nih.gov/11346394

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.

B M Melia, D H Abramson, D M Albert...

https://pubmed.ncbi.nlm.nih.gov/11158813

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.

https://pubmed.ncbi.nlm.nih.gov/9744369

The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma II: initial mortality findings. COMS report no. 10.

https://pubmed.ncbi.nlm.nih.gov/9645716