res something called "randomization", which means 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 sophisticated 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 rigorous study method shows that the experimental treatment is better, it becomes the new standaIn almost all cases, 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 available right up front, and you should inquire about this. However, in most cases,depending upon the tumor 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 tumors are included, their stage and what type 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. 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.

INVESTIGATIONAL TREATMENT or CLINICAL TRIALS There are thousands of clinical trials available 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 type of trial and type 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 primary purpose is to determine the dose 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 available 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 benefit for each particular type of cancer.

If an agent/drug shows some good effect against a particular type 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 means 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 sophisticated 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 rigorous study method shows that the experimental treatment is better, it becomes the new standar

It is never too early to inquire about research protocols and to look into where the options might take you. 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.

INVESTIGATIONAL TREATMENT or CLINICAL TRIALS There are thousands of clinical trials available 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 type of trial and type 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 primary purpose is to determine the dose 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 available 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 benefit for each particular type of cancer.

If an agent/drug shows some good effect against a particular type 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 means 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 sophisticated 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 rigorous study method shows that the experimental treatment is better, it becomes the new standa

always, at designated larger research centers. They are further broken down by type of trial and type 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 primary purpose is to determine the dose 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 available 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 benefit for each particular type of cancer.

If an agent/drug shows some good effect against a particular type 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 means 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 sophisticated 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 rigorous study method shows that the experimental treatment is better, it becomes the new standa

rapy.

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 benefit for each particular type of cancer.

If an agent/drug shows some good effect against a particular type 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 means 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 sophisticated 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 rigorous study method shows that the experimental treatment is better, it becomes the new standa

res something called "randomization", which means 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 sophisticated 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 rigorous study method shows that the experimental treatment is better, it becomes the new standard therapy. Thus good scientific practice and study design is absolutely essential so that we have the best possible therapy available to patients.

So should you participate and when? 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 very newest drugs available. Phase II trials are the next in line and are a very reasonable alternative 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 available 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 suggests that the new agent/drug is not worse than the standard therapy. However, there is a risk that it might be worse. On the other hand, there is a good possibility that it might be better. It comes down to personal choice and a long risk/benefit 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