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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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