Clinical trials and cancer

What are clinical trials for cancer?

New and exciting developments in the treatment of cancer for all age groups are occurring in the medical community. A clinical trial is a research study that compares many children from across the world with the same type of cancer and evaluates their treatment, side effects, and survival. A clinical trial is primarily used to discover the best treatment with the least side effects and the greatest survival for certain types of cancer. Clinical trials, by comparing large numbers of children with cancer and their specific treatment, have led to the vast improvements of cancer treatment from past years.

Why are clinical trials conducted?

A clinical trial is only started when there is some reason to believe that the treatment being studied will improve the overall treatment for that cancer. Researchers conduct studies for these new treatments to determine:

• How well do they work?
• Do they work better than previous treatments?
• What are the side effects?
• Are the side effects worth the overall benefit?
• Which type of cancer and patients would it benefit the most?

Protocol and roadmap for treatment

A clinical trial for the treatment of cancer usually involves the use of a protocol and a roadmap. A protocol describes the details of the course of treatment, medications to be given, blood work and evaluations that may be needed before, during, and after treatment. A protocol is written to ensure that a child being treated on a specific protocol is receiving the same medications, blood work, and tests as any child on the same protocol at a different hospital. In order to compare treatments and results from children across the nation, they need to have been treated in the exact same manner.

A roadmap is a schedule used for the protocol. A roadmap helps parents and healthcare providers know when medications and tests are due. A roadmap for the entire course of study is provided when the child begins a clinical trial. If the course of treatment is two years, a roadmap for the two years will be provided that lists a schedule for each day/week during that time.

A roadmap helps parents and children know when certain procedures may be done, how many days chemotherapy or radiation are to be given, how many nights need to be spent in the hospital and how often blood work may be done. A roadmap is followed as closely as possible, however, some changes in the schedule may occur due to unexpected events, such as infection or severe side effects with treatment.

If a child is in a study, their results and information will be compared to other children on the same study or protocol. Any side effects, blood work and response to treatment will be used as statistical data to compare the treatment to other treatments. This information is kept confidential and is used to determine the best treatment for the child's specific cancer.

Your child may be asked to participate in a clinical trial for the treatment of their type of cancer. Enrollment in any clinical trial is voluntary and enrollment can be stopped at any time. Taking part in a clinical trial does not prevent the child from getting any other medical care they may need. Your child's physician will explain to you which, if any, clinical trials are being conducted for your child's cancer and what will be expected in terms of risks, advantages, side effects, tests and any costs that may be associated with the study.