Expert Analysis Highlights:

• Clinical trials serve two purposes: Offering patients the newest treatment options and advancing scientific knowledge for future patients
• Below are some useful questions you should ask when deciding whether or not to participate in a clinical trial
• To find out if there is a trial in the area you need treatment, check out clinicaltrials.gov where all trials are registered
• For more information about clinical trials, click on the following link to patientresource.net

The phrase “Clinical Trials” means one of two things to most people: An opportunity to get the latest and greatest new treatment, or a futile human experiment with no major benefit to them.  The truth is somewhere in between.  The bottom line is that it depends on the trial and its design.

To review, a clinical trial is a program offered by some hospitals which assigns you randomly to receive standard treatment or a new treatment for which the potential benefit is not yet proven.  Some trials have 3 “arms” or treatment paths.  The key to a good research study from a design standpoint is that patients are randomly assigned to a treatment path and then the outcomes are compared.  This is the most scientifically valid way of assessing how good the treatments work.

Here are some useful questions you should ask when deciding whether or not to participate in a clinical trial:

• What is the benefit seen in previous studies of the new treatment being studied in the trial?
• Does the new treatment being studied work by a different mechanism (i.e. a novel treatment) compared to the standard treatment?
• Where did the idea for the clinical trial come from?
• What are the quality of life and survival differences likely if I do not participate in the trial?

For some trials the new treatment may be very promising, while for other trials, the benefit may be marginal or even negligible based on prior studies.

For your protection, all clinical trials are governed by rules which hospitals are ethically and legally obliged to follow.  The rules are: 1) If the benefit of one of the treatment options is clearly apparent during the course of the study, the study must be ended early so that the results can be disseminated and patients do not have to continue a course of treatment which is known to be inferior, 2) You must be informed of every aspect of the design of the study, 3) You can opt out of the trial at any time, and 4) You are entitled to see the results of the study once completed.

Clinical trials serve two purposes: Offering patients the newest treatment options and advancing scientific knowledge for future patients.  Consider it not just a way of getting a new treatment, but also a way of helping inform future patients with a similar cancer.  In general, clinical trials provide hope for patients whose treatment options might otherwise be limited.  Many trials are managed on a multi-institution level, making the trials available on a local level for many patients.

To find out if there is a trial in the area you need treatment, check out clinical trials.gov where all trials are registered.  There you will be able to find out what the treatment arms are, whether the trial is open of closed to new patients, and where to go to see if you’re a candidate.

Expert Analysis Highlights:

• This video provides patients with the chance to see what actually happens during the course of radiation treatment
• On a daily bases there is no pain or discomfort with the treatment
• Treatment course can extend anywhere from 2-8 weeks
• Side effects are highly dependent on the region of the body being treated and the total dose

Radiation treatments are used in the majority of patients with cancer, and yet most patients have little idea of what to expect. This video is helpful in showing what happens during the course of a single radiation treatment. Some take home messages include that the technology has become relatively sophisticated, that the treatment has to be precisely delivered to one defined area of the body, and that on a daily bases there is no pain or discomfort with the treatment.

Prior to this patient’s treatments, a series of events had already taken place. You can see in the video that the patient’s head is immobilized by plastic mask that is fastened onto the table. The purpose of this and other forms of immobilization is to assure that the carefully planned treatment is able to be reproduced each day when the patient comes for their daily treatment. Treatment course can extend anywhere from 2-8 weeks and the ability of the treatment to hit its target is highly dependent on the ability to precisely reproduce the position of the patient each day. Also prior to the treatment, a CAT scan of the patient while he was immobilized in his mask was obtained. This information is transferred to treatment planning computers and the doctor outlines the targeted region and the normal tissues to avoid. Working with his team, the doctor then helps determine the optimal angle of beam entrance and exit and the shape and intensity of each field. In the video, four fields were used: one from the front, one from the back and one from each side. These four beams will have a mutual intersection point at the targeted region where the addition from each beam will result in a selectively high dose to this region. Within the treatment head of the machine are a collimation system that can shape the beam edges into almost any shape which further adds to the precision of the dose delivery.

Radiation treatments are a scary endeavor for any patient and the treatment can cause some side effects that are highly dependent on the region of the body being treated and the total dose. What I liked about the video is that it provides patients with the chance to see what actually happens within the treatment room. In doing so, I hope you were left with the impression that it’s not that bad and when it is warranted it can provide a great service to cancer patients.

This is an interesting approach with cryosurgery for prostate cancer that is very early-stage and confined to small portions of the prostate gland. This video was made with the urological cancer specialists at Duke Medical Center in Durham NC. As with many cancers, if prostate cancer is detected early then the options for more limited treatments, such as cryosurgery or radiation seeds, can be a consideration, alongside the more conventional treatment approaches of prostatectomy or external beam radiation therapy.

I am still an advocate for PSA tests in men over 50. Men with prostate cancer need to be fully informed about all the options, along with their benefits and risks, so they can participate in the final decision about which treatment is best for them.

A diagnosis of cancer can be scary, and understanding a treatment plan confusing. To gain more information, it is sometimes wise to seek a second opinion or advice from another qualified cancer specialist or group of specialists before or even after you begin treatment.

If you are asked to consider alternatives, such as surgery or radiation or chemotherapy or hormone therapy, you might want to hear from each type of oncologist who gives that treatment. It’s all right to look at all your options. A second opinion could save your life or better protect your quality of life.

Options for getting a second opinion:

- Talk to a cancer specialist in another specialty or medical group.

- Ask that your case be presented to a tumor board or tumor conference at your hospital.

- Ask to get a second opinion on your pathology reading, especially if there is any controversy in making a complete diagnosis.

- Seek the advice of a renowned cancer expert usually in a comprehensive cancer center especially if your situation is complicated or uncommon.

For more information, see our companion website: www.patientresource.net. Here’s some of the content from patientresource.net that you may find useful:

Getting a second opinion involves asking another cancer specialist or group of specialists to review your medical records and confirm your doctor’s diagnosis and treatment plan. Other specialists can confirm your pathology report and stage of cancer and might suggest changes or alternatives to the proposed treatment plan. They can also answer any additional questions you may have. There is often collective wisdom gained from the experience and opinions of different oncology specialists who are experts in your type of cancer.

There are lots of reasons for seeking a second opinion. Some doctors may favor one treatment approach, while others might suggest a different combination of treatments. Doctors in each oncology specialty bring different training and perspectives to cancer treatment planning. Another doctor’s opinion may change the diagnosis or reveal a treatment your first doctor was not aware of. You need to hear arguments for all of your treatment options. A second opinion is also a way to make sure your pathology diagnosis and staging are accurate, and that you are aware of clinical trials that you might want to consider.

If you are asked to consider alternatives, such as surgery, radiation, chemotherapy or hormone therapy, you might want to hear from each type of oncologist who provides that treatment. It’s all right to look at all your options; a second opinion could save your life or better protect your quality of life. Most doctors welcome another doctor’s opinion.

Second opinions are also valuable if you live in a small town or rural area where there may not be as many oncology specialists, especially if you have an uncommon type of cancer or might need a highly specialized or complicated type of care. If so, you may want to get an opinion from specialists at a larger medical center or comprehensive cancer center with particular expertise in treating your type of cancer.