About The COMS

Clinical Trials for Choroidal Melanoma

What is a clinical trial?

A clinical trial is a research program carried out by doctors and other scientists to evaluate a promising new treatment or to compare it to a more traditional or standard treatment. A new treatment may be promising because it appears to give a better outcome (e.g., longer life), to have fewer side effects, to cost less, to be more widely available, or to be easier to carry out than the standard treatment. A clinical trial is designed to find better ways to take care of patients with cancer or other illness or to minimize undesirable effects of treatment. Clinical trials help us to discover which treatments are safest and most effective for a majority of patients with a particular condition.

Why are clinical trials important?

Advances in medicine are the result of new ideas and approaches developed through research. Through clinical trials, we learn which approaches are more effective than others. This kind of research study is the best way to test a new treatment. For example, treatments which are now standard for leukemia, breast cancer, and diabetic retinopathy were first shown to be effective in clinical trials. In some cases, new treatments have been shown to be less helpful than the standard treatment, or than no treatment at all. In other cases, both new and standard treatments were shown to be equally ineffective.

What is the Collaborative Ocular Melanoma Study?

The Collaborative Ocular Melanoma Study, or COMS for short, is a set of clinical trials designed to evaluate the treatments doctors use for their patients with choroidal melanoma. The goal of each clinical trial is to learn which therapy of those under evaluation leads to the longest lifespan for patients with choroidal melanoma. Because both survival and the type of therapy available depend on the size of the tumor, treatments for medium tumors are being evaluated separately from treatments for large and small tumors.

The quality of life of patients with medium choroidal melanoma is also being assessed. Patients are interviewed by telephone before enrolling in the COMS and several times after treatment.

COMS clinical trials are funded by the National Eye Institute and the National Cancer Institute of the National Institutes of Health of the United States, and are being conducted at more than 40 medical centers in the United States and Canada. Important information collected about the patients who take part in each COMS clinical trial is forwarded to a central data center called a Coordinating Center. The quality of life interviewer, who conducts telephone interviews with medium tumor patients, is also located at the COMS Coordinating Center. The COMS Coordinating Center is located at the Johns Hopkins Medical Institutions in Baltimore, Maryland.

How will a clinical trial be conducted for patients with medium tumors?

For patients with medium tumors, it is not known whether radiation therapy or enucleation provides the better chance of a normal lifespan. If your doctor knew that your lifespan would be the same with either treatment, he/she might recommend radiation with the hope of preserving some vision, at least for a while. On the other hand, if doctors knew that enucleation promised a longer life, they usually would not recommend radiation treatment even if radiation would not cause loss of vision. In the COMS, half of the patients with medium tumors will be treated with radioactive plaques (Group A) and the other half will be treated in the standard way with enucleation (Group B). The two groups of patients will be compared to see whether radiation therapy or standard enucleation results in a longer life for patients with medium tumors.

When two forms of therapy are being compared in a clinical trial, how will a patient be assigned to one type of treatment or the other?

In a clinical trial, one group of patients receives the"standard" or more common treatment and another receives an alternative treatment which is compared to the standard. For example, as in the COMS clinical trial for medium tumors, one group may receive the usual surgical treatment of a certain cancer while another group with the same type of cancer may receive radiation therapy to see which one most often leads to longer life. The doctors do not know which treatment is better. Both treatments have been effective in ridding some patients of cancer. No one knows which treatment gives the patient a better chance of a normal life-span or whether they are equally good. Some patients may not be eligible for a clinical trial because they have other medical problems. In such cases, the doctor does not recommend that enrollment in a clinical trial be considered. To prevent any bias or prejudice of the patient or the doctor from influencing the results of the clinical trial, a patient is assigned to one treatment or another by randomization. When the patient and the doctor agree to randomization, the treatment received by the patient is selected by chance. The patient has an equal chance of receiving either treatment. The doctor has already judged that the patient is equally likely to benefit from either treatment based on current knowledge.

If your doctor asks you to consider a trial using randomization, he or she is uncertain which of two treatments will be better for you and is equally willing for you to have either one. If your doctor believes that you would benefit more from one particular treatment than from the other, he or she will recommend that treatment to you and will not ask you to take part in a clinical trial.

How will patients be followed in the Collaborative Ocular Melanoma Study after Treatment?

After enucleation, several clinic visits are required so that the surgeon can monitor the healing process. Once the patient recovers from enucleation surgery or plaque therapy, visits are scheduled twice each year for five years and once a year for an additional five years or longer to monitor the patient's health, observe the tumor's response to radiation when plaque therapy is used, monitor the status of the other eye, and look for any possible complications of the condition or the treatment. Sometimes there may be more frequent visits depending upon the needs of the patient. It is very important that every patient return for these follow-up visits. If a patient moves to another part of the country, arrangements will be made for continued follow-up care in another COMS center. Telephone interviews to determine the patient's own assessment of health and vision are scheduled near the times of clinic examinations. Patients who move can continue to participate in these telephone interviews.

Although certain evaluations should be conducted by your COMS physicians, participation in the COMS does not mean that a patient should stop seeing personal physicians for medical care. Your COMS doctors will keep your personal doctor informed about COMS examinations and treatment and will cooperate fully in your total medical care.

What happens to information about patients who take part in the Collaborative Ocular Melanoma Study?

Aside from discussions with each patient's personal doctors, no information that identifies the patient is given to anyone outside the COMS. A complete set of medical records is kept for each patient taking part in the COMS; access to those records is restricted to safeguard the patient's privacy. When information about a patient is sent to the COMS Coordinating Center, the information is coded so that only the patient's own COMS doctor and clinic coordinator can identify him or her. At the COMS Coordinating Center, the information from all patients is pooled and analyzed to see which treatment is better. When clinically important information becomes available, these findings will be reported to the patients and published in medical and scientific journals, so that all doctors as well as future patients with choroidal melanoma can benefit from new knowledge. In these reports, individual patients are not identified.

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