From the FCCTC editorial board: We have chosen to publish the following article by patient advocate, Steve Dunn, for all of you who may be searching for new, investigational therapies for the treatment of your or a loved one’s cancer. We feel that this is a very well written introduction to this difficult and sensitive topic, and one which we hope will answer many of your questions. We have provided editorial comment, where appropriate, to explain any confusing or difficult medical terms or situations, and hope that you will contact us by email or telephone if you have any further questions. November 1, 2004

When to do a Clinical Trial Search

All too often I get e-mail from patients who are interested in clinical trials, but who don't qualify for any right now because they've rushed into standard treatment before thinking about trials. If you are interested in the clinical trial option, it is critically important that you investigate trials at the appropriate times, and usually that's sooner rather than later! Often, there are several possible times when you might be able to get into a trial, so if you have already missed an opportunity, don't despair. Instead, learn how the system works and when to search, so you'll be prepared for the next window of opportunity. Of course, a trial may not turn out to be your best option, but you may not have a chance to find out unless you search, and search at the right times!

SPECIFIC SITUATIONS IN WHICH SEARCHING FOR TRIALS IS URGENT!

If you have just been diagnosed with apparently localized cancer

Often the treatment for early or localized cancer [cancer which has not yet spread from its site of origin] seems medically routine and clinical trials aren't considered at all. But in localized cancer additional treatment [following local therapies such as surgery or radiation] to prevent recurrence called, adjuvant therapy, can increase your odds. There may be clinical trials which aim to improve adjuvant therapy even when some form of adjuvant therapy is standard. For some cancers there is no proven adjuvant therapy, but there may be promising trials of adjuvant therapy.

Some clinical trials of adjuvant, and especially neoadjuvant therapy [treatment given prior to the definitive local therapy which removes or kills the cancer], require that you sign up before your surgery or primary treatment. If you rush into surgery without doing a trial search, you may count yourself out of valuable trials! Some trials use the primary tumor to make a vaccine which is then administered as adjuvant therapy. If your primary tumor is gone, obviously it's too late! Neoadjuvant trials involve giving treatment such as drug or radiation therapy before the surgery. Again, if you've already had the surgery it's too late.

If you have just had surgery for apparently localized cancer

Many adjuvant trials do not require that you sign up before surgery, but almost all adjuvant trials require that you enroll within a few months [and sometimes days] of surgery. If you wait too long, you may not qualify! Also if you start an adjuvant therapy outside of a clinical trial, you may disqualify yourself for any trials of newer adjuvant therapies. Note that in some cases the primary treatment is something other than surgery, such as radiation therapy, but the basic considerations for when to search are the same.

If you have just had a recurrence or have just been diagnosed with advanced cancer

It's especially important to search for trials before starting treatment if standard treatment is not terribly effective, as is the case with many advanced cancers. If you are on treatment you may be disqualified from trials as long as you are on treatment and as long as your cancer hasn't gotten worse. Merely having had treatment for your recurrence or advanced cancer can disqualify you from some trials which may require that you haven't tried any other treatment for the recurrence, or which may require that you haven't used certain drugs. Note that if there is a somewhat effective treatment for your cancer, you may actually be required to have tried that before qualifying for trials. If this is the case for your cancer you will discover it when you do your search.

If you have just learned that your treatment for advanced cancer isn't working

You'll want to look into trials before starting another treatment. You usually can't start a trial until several weeks after completing your last treatment and recovering from its side effects, so you should have a little time to investigate now [but do not delay].

SITUATIONS IN WHICH SEARCH FOR TRIALS IS LESS URGENT

While doing a clinical trial search may not be urgent, you may still want to keep tabs on what's out there in case you need it. If you are currently disease free, and don't qualify for trials of additional treatment, you might want to see what's out there for patients who have a recurrence. The risk of recurrence after the initial treatment varies from close to zero to nearly 100%, depending on the situation. If your risk is high, you will probably be more motivated to keep tabs on new developments than if it's low!

If you have a clinical emergency

Many people believe that after a diagnosis of cancer there is not a day to lose in starting treatment. The truth is cancer is usually a relatively slow process, and in most cases delaying cancer treatment for a short time in order to investigate your options isn't a problem. But there are real exceptions, and if it's truly an emergency, you can't wait to investigate trials. You need to [be guided by, and to] act on your doctor's advice now!

If you are on treatment now

You normally won't qualify for a trial until after you complete your current treatment.

If you have started or completed adjuvant therapy

Then you probably won't qualify for a trial unless you have a recurrence. While you may want to look into what the most promising options would be in case do you have a recurrence, it isn't urgent.

If you've been disease free for some time

If your primary therapy has worked and it's been more than a few months since you finished treatment, you probably don't qualify for any adjuvant trials since these usually require registration within a few months of completing the primary therapy. Again you may want to keep tabs on what's out there for advanced disease in case you do have a recurrence [and you may also qualify for a cancer prevention study which could lessen your chances of developing a new cancer].

This CancerGuide Page By Steve Dunn. © Steve Dunn. Last Updated: November 23, 2001