What Are Clinical Trials for Colorectal Cancer?

Researchers are always looking for better ways to treat colorectal cancer and other conditions. Clinical trials are ways to try new medical treatments, medications, or devices before they’re widely available.

Some people with colorectal cancer or other conditions are reluctant to take part in clinical trials. One reason is that they’re afraid they’ll get no treatment at all. But that’s not the case.

You’ll either get the most effective therapy that’s already available or a new treatment that’s being tested to see if it works better. A clinical trial is the only way to find out what’s best. By taking part, you’ll help scientists and doctors find out.

There are some other advantages. You wouldn’t have to pay for your care, and you’d probably get free medical evaluations as part of the trial.

Before you sign up, you should talk to your doctor to make sure you know what’s expected (for instance, if you’ll have to travel for the trial and how long it lasts).

When researchers study a new medical treatment for the first time in people, they don’t know exactly how it will work. With any new treatment, there are possible risks and potential benefits. Clinical trials help doctors discover the answers to the following questions:

  • Is the treatment safe and effective?
  • Is it better than treatments that are already available?
  • What are the possible side effects and risks?
  • How well does the treatment work?

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What Are Clinical Trial Phases?

Researchers do clinical trials in phases. Each one is designed to find out specific information and builds on the previous phases.

You may be eligible for clinical trials in different phases, depending on your overall condition. Most people take part in phases III and IV.

Phase I: A small number of patients get the new treatment. The goal is to find out the best way to give it and how much can be given safely.

Phase II: More people get the treatment, as researchers learn more about its safety and how well it works.

Phase III: Researchers compare the new treatment with the standard treatment in a large number of people.

Phase IV: Researchers apply the new treatment more broadly. For example, they may use a new drug that was found to be effective in a clinical trial together with other medicines to treat a disease or condition in a certain group of people, and check on long-term effects.

Benefits

The big advantage is that you may get a new treatment for colorectal cancer before it’s widely available to the public.

It’s also a way to help research treatments and procedures that would help others who have colorectal cancer.

Lastly, it could help with your medical bills. The company or agency that sponsors the study may pay for many of the tests and doctor visits directly related to the trial. You’ll want to confirm that in advance with the trial’s staff.

Risks

Part of the point of a clinical trial is to find out about risks and side effects. So you may not know those in advance. Keep in mind that most treatments, as well as the disease or condition itself, have side effects.

If you join a trial, the researchers will tell you about any known side effects that you might have, and they will update you during the trial about problems that happen or become known during the trial.

How Would It Affect My Treatment?

You may get more examinations and tests than if you weren’t in a trial. The researchers need information from those to track how you do and collect study data.

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Depending on the type of clinical trial, you may need to stop or change the medication you are taking. You may also need to change your diet or any activities that could affect the outcome of the trial.

You won’t know whether you get the experimental medicine or a placebo (which has no active ingredients) if it’s a “placebo-controlled” trial. And if it’s also a “double-blind” trial, the people who give you the treatment won’t know, either.

This “blinding" helps the researchers separate the real effects of a treatment from the "placebo effect" -- positive changes people often get merely by being treated at all, and not as a result of any particular treatment.

The researchers will closely watch how you’re doing and will keep and review records of that.

The personal information gathered about you during the clinical trial will remain confidential. It won’t be reported with your name attached.

What Is Informed Consent?

Informed consent means that as a colorectal cancer patient, you will get all available information so you know what’s involved in a specific clinical trial. The doctors and nurses conducting the trial will explain the treatment to you, including its possible benefits and risks.

The researchers will give you an informed consent form to read and consider carefully. Before you sign it, find out as much as possible about the clinical trial, including what risks you may face. Ask the doctor or nurse to explain parts of the form or the trial that aren’t clear.

If you decide to participate, you will sign the consent form. If you don’t want to take part, you don’t have to sign the form. If you choose not to join in the trial, it won’t affect your medical care, and you won’t get the experimental treatment.

The informed consent process is ongoing. After you agree to participate in a clinical trial, you’ll get any new information about your treatment that may affect your willingness to stay in the trial.

Even after you sign the informed consent form, you’re free to leave the trial at any time, without penalty. You’d then go back to your regular medical care.

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Who Can Take Part?

It depends on the trial. The researchers may need someone who’s in a certain stage of colorectal cancer, for instance. If you’re a good match, you may be able to participate. In some cases, you may need to get certain tests to confirm that you’re a good candidate.

Can I Change My Mind?

Yes. If at any time you feel that it’s best to leave the trial and use other treatments, you can do so.

10 Questions to Ask First

You may want to ask these questions before you agree to join a clinical trial:  

  1. What’s the purpose of this trial?
  2. What kinds of tests and treatments are involved? How will I get them? 
  3. What’s likely to happen in my situation with or without this new treatment?
  4. Are there standard treatment options for my colorectal cancer? How does the study compare with them? 
  5. How could the clinical trial affect my daily life?
  6. What side effects from the treatment can I expect?
  7. How long will the clinical trial last?
  8. Will it take extra time on my part?
  9. Will I have to stay in a hospital? If so, how often, and for how long?
  10. If I decide to leave the clinical trial, will it affect my medical care? Will I need to change doctors?

How Do I Find a Clinical Trial?

You may want to check these websites for information and services to help you find a colorectal cancer clinical trial.

TrialCheck

The nonprofit Coalition of Cancer Cooperative Groups developed this site. It’s an unbiased cancer clinical trial matching and navigation service that lets people search for cancer trials based on disease and location.

National Cancer Institute

This website lists more than 6,000 cancer clinical trials and explains what to do when you find one that you think is right for you.

ClinicalTrials.gov

You’ll find up-to-date information on federally and privately supported clinical trials for cancer.

CenterWatch

This website lists industry-sponsored clinical trials that are recruiting patients.

WebMD Medical Reference Reviewed by Minesh Khatri, MD on October 20, 2016

Sources

SOURCE:

FDA: ''Participating in Clinical Trials.''

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