In almost all situations, initial therapy should be a state of the art plan including one or several of the following options: surgery, chemotherapy, radiation. There are some research protocols which are obtainable right up front, and you should inquire about this. However, in most situations,depending upon the tumor kind, 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 tumors are included, their stage and what kind of therapy has been given to date. It is never too early to inquire about research protocols and to look into where the options might take you. however you should know that research protocols open and close regularly when the desired number of patients on protocol has been reached. consequently, a trial which is open today, may not be open tomorrow.
INVESTIGATIONAL TREATMENT or CLINICAL TRIALS
There are thousands of clinical trials obtainable on any given day for various forms of cancer. For gynecologic cancers alone, there are hundreds across the country, usually, but not always, at designated larger research centers. They are further broken down by kind of trial and kind of cancer that is targeted. These studies can be divided into three general types.
In a Phase I trial a new treatment is being studied for the first time in humans, which has good laboratory and animal study evidence for efficacy. The dominant purpose is to determine the measure levels that can be tolerated safely and side effects. Usually these are best suited for patients who have progression of their cancer despite use of all obtainable standard therapy.
The next step is a Phase II trial, in which the treatment is offered to patients who have a variety of cancer types. These patients also have cancer which is progressing despite all standard therapies. Phase II trials are used to determine if the treatment has any assistance for each particular kind of cancer.
If an agent/drug shows some good effect against a particular kind of cancer, a Phase III study is initiated to see if the agent/drug is better than the known best treatment against that particular cancer. This requires something called “randomization”, which method that the patient will get either the standard therapy or the experimental therapy determined by chance. This is equivalent to the flip of a coin, but more complex techniques are used. The goal for randomization is to have each treatment arm (experimental and standard) contain the same number and sort of patients with respect to extent of disease, age, past treatment, etc. This is crucial, because if this scientifically demanding study method shows that the experimental treatment is better, it becomes the new standard therapy. consequently good scientific practice and study design is absolutely basic so that we have the best possible therapy obtainable to patients.
So should you participate and when? Phase I trials have the most possible toxicity and side effects associated with them. But if everything else has failed, and you nevertheless want to give it a try, this offers a shot at the very newest drugs obtainable. Phase II trials are the next in line and are a very reasonable different if standard therapy is not working very well, and you do not wish to risk the unknown levels of side effects inherent in Phase I trials. Phase III trials are made obtainable when a very promising therapy (based on Phase I and Phase II information) is felt to be possibly better than the standard therapy. At the very least, when offered, it is felt that the Phase I and Phase II evidence indicates that the new agent/drug is not worse than the standard therapy. However, there is a risk that it might be worse. however, there is a good possibility that it might be better. It comes down to personal choice and a long risk/assistance discussion with your treating physician.
The best compendium of research trials can be found on the National Cancer Institute’s and the American Cancer Society’s websites. For additional information regarding Gynecologic Cancers be sure to also visit www.gyncancerdoctor.com