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Clinical Trials  

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Our clinic is a member of the Children's Oncology Group (COG) which is a newly formed cooperative group created to further improve the cure rate of childhood cancers. The members of this group include the Pediatric Oncology Group (POG) of which our clinic has been a member for many years, Children's Cancer Group (CCG), the Intergroup Rhabdomyosarcoma Study Group (IRSG), and the National Wilms' Tumor Study Group (NWTSG). All of these groups and now the new COG are National Cancer Institute-sponsored clinical cooperative groups. With this new group there will be the opportunity to look at increased numbers of patients on specific clinical studies and to proceed with completing research and improving cancer treatments more quickly. The advances and overall cure rates for childhood cancers have happened largely as a result of the clinical trials done by these cooperative groups.

What Is a Clinical Trial?

A clinical trial is one of the final stages of a long and careful cancer research process. Doctors follow a specific treatment plan called a protocol. Studies of new protocols are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are effective and safe. Many of these studies are designed to refine and improve on treatment that has worked in the past.

Most clinical research that involves the testing of a new drug progresses in an orderly series of steps called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of three phases:

Phase III trials: These studies compare the current standard of treatment with a new combination of drugs, or a new surgical procedure. The new treatment plan is being tested in order to improve the current standard of treatment. A participant will usually be assigned to the standard treatment group or the new treatment group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.

Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer. A patient would enroll on a Phase II trial when the current standard of care has been ineffective in stopping the cancer growth.

Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A Phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen. A patient enrolls on a Phase I trial when all other treatments have been ineffective.

If you would like to learn more about clinical trials you may check with the following:

Call:

  • Cancer Information Service's toll-free number 1-800-422-6237 to request a free copy of the brochure What Are Clinical Trials All About? This is an NCI publication designed to inform patients and families.

  • National Brain Tumor Foundation at 1-800-934-2873 for their fact sheet on clinical trials.

Web sites:

National Cancer Institute
http://www.cancer.gov/clinicaltrials

Centerwatch Clinical Trials
http://www.centerwatch.com

Oncolink
http://www.oncolink.upenn.edu/clinical_trials

Pediatric Oncology Resource Center
http://www.acor.org/ped-onc/treatment/clintrial.html

U.S. National Institutes of Health
http://clinicaltrials.gov

 

 

 

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