Cancer Clinical Trials: what does “significant” mean?

When we hear the words there was a significant treatment effect, you would naturally assume that significant means large, important, or noteworthy. This may be true—but not necessarily. More often than not, significant refers to statistically significant, which means that the difference between the two groups of patients was statistically meaningful and unlikely to be random.

          Statistical significance is an important concept. Without measuring the statistical significance of study results in cancer treatment, it is possible that any effects may not even be real but rather just chance. However, statistical significance is not enough. Another medical term—clinically significant—means “important to patient care.” This is what we are after. If a small effect is statistically significant, it may still not be large enough for us to care much about it. Watch out for the word significant, and assume it’s likely “statistics-speak” and not necessarily the large, important improvement you might think.

Does joining one cancer clinical trial disqualify you from joining another trial?

Participating in one clinical trial does not necessarily disqualify you from future trials, as long as you meet the future study criteria. Many people participate in more than one clinical trial over time. Rules for trial participation do take into consideration therapy that you have received prior to joining a trial, and a prior treatment that you have received—either standard or experimental—might make you ineligible. If you already know you might be interested in a specific trial sometime in the future, check with your doctor or clinical trial site to see if the treatment decisions you make today could get in the way later. For the most part, however, many other clinical trials are available, and even if one particular study is off limits to you, another is likely to become available.

The big trends in medical treatments for cancer

Medications are the mainstay of treatment for those cancers that by their nature or because they have spread, cannot be removed surgically or eliminated with radiation.  Medical treatments are also often added to surgery or radiation to kill the few cancer cells that may have escaped and reduce the chance of cancer coming back.  The broad trends that are driving research into new medications for cancer include:

·        New chemotherapy drugs and combinations of drugs

·        New ways to manipulate the hormones that drive certain cancers (primarily breast and prostate cancer)

·        More specific and targeted therapies that are sometimes referred to as “smart bombs.”  These types of treatments are designed to attack very specific mechanisms that drive cancer growth and spread.  A variety of technologies make targeted therapy possible.  Some are artificial antibodies, synthetic small chemical molecules, and gene-directed therapies

·        Harnessing the immune system to fight cancer

·        All cancer therapy is likely to become more personalized (individualized) with treatments selected to match each person’s unique cancer.  

New Phase III Cancer Clinical Trials - December 2011

     Our search, carried out on December 22, showed 22 new phase III trials registered in the last 30 days.  We will highlight two that explore immunotherapy in two very different contexts.  
     The first trial compares the use of the patient's own stimulated killer cells (a part of one's natural immune system) to the use of chemotherapy in advanced lung cancer.  The study is being carried out in China, so it is likely inaccessible to most US cancer patients, but it is a good example of how immunotherapy continues to be a major direction for cancer clinical trials.  
     The second trial tests a vaccine product called NeuVax (TM) to determine if the vaccine can prevent the relapse of breast cancer.  Patients who have early stage node positive breast cancer that has low or intermediate expression of the HER2 protein are eligible.  Experimental treatment follows the completion of standard treatments such as surgery, radiation, and chemotherapy.

     You can click on the hyperlinks above to see each individual trial or click here to learn more about both of them:

New immunotherapy trials Dec 2011 (click here - link expires March 21, 2012)
     To see all 22 new phase III trials registered in the last 30 days, click here:
All new phase III cancer trials Dec 2011 (click here - link expires March 21, 2012)

Welcome to the cancer clinical trials blog!

Simple, accessible, trustworthy, and practical information about cancer clinical trials and the experimental therapies they offer is what we aim to bring you here.  We welcome your comments, suggestions, and questions.  This blog is for people with cancer, their families, and their friends.  For many people with cancer, today’s treatments are imperfect or even have substantial shortcomings.  Clinical trials may offer something new or different, but unless your regular bedtime reading includes the New England Journal of Medicine or the Journal of Clinical Oncology, the world of clinical trials can seem remote, mysterious, and even inaccessible.  Together, we can change that.  We invite you to join this community and hope you will both learn about clinical trials and teach us by sharing your perspective, experiences, and questions.  Welcome!

Tom and Larry