Ovarian Cancer Clinical Trials: What & When
In almost all cases, initial therapy should be a state of the art plan incorporating surgery and chemotherapy. However, some research protocols are available up front that you should inquire about. Usually, depending upon the cancer cell type, research medicines or therapies may be considered after the initial therapy and/or therapy after first recurrence fails.Research protocols are very specific about what types of cancer are included, their stage and what type of therapy has been given up to that point. But it is never too early to inquire about research protocols. On the other hand, you should know that research protocols open and close regularly when the desired number of patients on protocol has been reached. Therefore, a trial which is open today, may not be open tomorrow.
Where Do I Find Ovarian Cancer Clinical Trials?
Thousands of clinical trials are available on any given day for various forms of cancer. For gynecologic cancers alone, there are hundreds across the country. Usually, but not always, they are available at designated larger research centers. The largest resource on the internet is the National Cancer Institute clinical trials database.Before you try to find ovarian cancer clinical trials, you should know how clinical trials are further broken down by type of trial and type of cancer that is targeted. These studies can be divided into three general types, referred to as Phases.
Clinical Trial Phases: What Are They?
In a Phase I trial a new treatment is being studied in humans for the first time. This means there is already good laboratory and animal study evidence that it might work. The primary purpose is to determine the dose levels that can be tolerated safely and the side effects, so it is provided to patients with cancers of all types. Usually Phase I trials are best suited for patients who have progression of their cancer despite use of all available standard therapy.The next step is a Phase II trial, in which the treatment is offered to patients with a narrower range of cancer types. These patients also have cancer which is not responding to standard therapies. Phase II trials are used to determine whether or not the treatment works for each particular type of cancer.
If an agent or drug is found to be effective against a particular type of cancer, a Phase III study is initiated to see if the agent/drug is better than the best known treatment against that particular cancer. This requires something called "randomization," which means that the patient will get either the standard therapy or the experimental therapy determined by chance. In essence, which treatment you get is determined by something like the flip of a coin, although more sophisticated computer techniques are used.
The goal for randomization is to have each treatment arm (experimental and standard) contain the same number and sort of patients. This means that they have similar extent of disease, age, past treatment, etc. If this scientifically rigorous study method shows that the experimental treatment is better, it becomes the new standard therapy. Thus good study design is absolutely essential so that we always have the best possible therapy available for patients.
When Should I Participate & What Phase Is Right For Me?
Phase I trials have the most potential toxicity and side effects associated with them. But if everything else has failed, and you still want to give it a try, this offers a shot at the newest drugs available. Remember, at this point no one knows how severe the side effects might be.Phase II trials are the next in line and are a very reasonable option if standard therapy is not working very well, but you do not wish to risk unknown severity of side effects.
Phase III trials are proposed only after Phase I and II trials have shown that the agent/drug might be better than the standard therapy. At the very least, at this point the medical evidence suggests that the new agent/drug is probably not less effective than the standard therapy. However, a Phase III trial might still show that it is worse. The hope, of course, is that it is better. It comes down to personal choice and a long risk-benefit discussion with your treating physician.
