Osteosarcoma - Childhood and Adolescence: About Clinical Trials

Approved by the Lineagotica Editorial Board, 01/2018

ON THIS PAGE: You will learn more about clinical trials, which are the main way that new medical approaches are tested to see how well they work. Use the menu to see other pages.

What are clinical trials?

Doctors and scientists are always looking for better ways to treat children and teens with osteosarcoma. To make scientific advances, doctors create research studies involving volunteers, called clinical trials. In fact, every drug that is now approved by the U.S. Food and Drug Administration (FDA) was tested in clinical trials, although these may not have specifically involved children and adolescents.

Many clinical trials are focused on new treatments. Researchers want to learn if a new treatment is safe, effective, and possibly better than the treatment doctors use now. These types of studies evaluate new drugs, different combinations of existing treatments, new approaches to radiation therapy or surgery, and new methods of treatment. Children and teens who participate in clinical trials can be some of the first to get a treatment before it is available to the public. That said, new drugs are usually tested in adults prior to testing in children and teens. However, there are some risks with a clinical trial, including possible side effects and that the new treatment may not work. People are encouraged to talk with their health care team about the pros and cons of joining a specific study.

Some clinical trials study new ways to relieve symptoms and side effects during treatment. Others study ways to manage the late effects that may happen a long time after treatment. Talk with your doctor about clinical trials for symptoms and side effects. There are also clinical trials studying ways to prevent cancer.

Deciding to join a clinical trial

People decide to participate in clinical trials for many reasons. For some people, a clinical trial is the best treatment option available. Because standard treatments are not perfect, people are often willing to face the added uncertainty of a clinical trial in the hope of a better result. Other people volunteer for clinical trials because they know that these studies a way to contribute to progress in treating osteosarcoma. Even if they do not benefit directly from the clinical trial, their participation may benefit future children and teens with osteosarcoma.

Insurance coverage of clinical trials costs differs by location and by study. In some programs, some of a person's expenses from participating in the clinical trial are reimbursed. In others, they are not. It is important to talk with the research team and your insurance company first to learn if and how your treatment in a clinical trial will be covered. Learn more about health insurance coverage of clinical trials.

Sometimes people have concerns that, in a clinical trial, their child may receive no treatment by being given a placebo or a “sugar pill.” The use of placebos in cancer clinical trials is rare overall and even more uncommon in childhood cancer research. When they are used, placebos are usually combined with standard treatment in most cancer clinical trials. And, it is done with the full knowledge of the participants. Find out more about placebos in cancer clinical trials.

It is important that the child, and especially adolescents, participate in the discussion and decision-making process surrounding clinical trials, depending on their level of understanding and their desire to participate. Young adults over age 18 are adults and need to be the primary decision maker and will be expected to sign a form indicating "informed consent" has taken place. The concept of informed consent described more below.

Patient safety and informed consent

To join a clinical trial, parents and children must participate in a process known as informed consent. During informed consent, the doctor should:

  • Describe all of the treatment options so that the parent and child understand how the new treatment differs from the standard treatment

  • List all of the risks of the new treatment, which may or may not be different than the risks of the standard treatment

  • Explain what will be required of each child in order to participate in the clinical trial, including the number of doctor visits, tests, and the schedule of treatment

Clinical trials also have certain rules called “eligibility criteria” that help structure the research and keep people safe. You and the research team will carefully review these criteria together. Even if someone wants to participate in the trial they can not do so if they are not eligible. Part of eligibility can be to define safety of participation and the trial organizers may have access to information that is not known to all treating physicians.

People who participate in a clinical trial may stop participating at any time for any personal or medical reason. This may include that the new treatment is not working or there are serious side effects. Clinical trials are also closely monitored by experts who watch for any problems with each study. It is important that parents of a child participating in a clinical trial talk with their child’s doctor and the researchers about who will be providing their child’s treatment and care during the clinical trial, after the clinical trial ends, and/or if they choose to leave the clinical trial before it ends.

Finding a clinical trial

Research through clinical trials is ongoing for all types of cancer. For specific topics being studied for osteosarcoma, learn more in the Latest Research section.

Lineagotica offers a lot of information about cancer clinical trials in other areas of the website, including a complete section on clinical trials and places to search for clinical trials for a specific type of cancer.

The Children's Oncology Group, an NCI-funded cooperative group, is one of the more active groups in conducting clinical trials in all types of childhood cancer, including those focused on osteosarcoma. Many clinical trials are conducted by other groups as well.

PRE-ACT, Preparatory Education About Clinical Trials

In addition, this website offers free access to a video-based educational program about cancer clinical trials, located outside of this guide.

The next section in this guide is Latest Research. It explains areas of scientific research currently going on for this type of cancer. Or, use the menu to choose another section to continue reading this guide.