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Approaches to Increasing Clinical Trial Access and Enrollment for Adolescents and Young Adults with Cancer.

One of the recommendations of the 2006 National Cancer Institute Progress Review Group (NCI PRG) was to increase inclusion of adolescent and young adult (AYA) cancer patients into clinical trials as a strategy toward the progress that needs to be made in the AYA cancer continuum. Indeed, it is my belief that expanded access to and inclusion in clinical trials is the only true way to increase the knowledge needed to improve outcomes for AYA patients. But there is much debate about how this can and should be accomplished. In this issue’s ‘‘Clinical Trial Spotlight,’’ we are proud to highlight the intergroup trial C10403 for acute lymphoblastic leukemia (ALL). This trial grew out of the abstract presented by Dr. Wendy Stock in 2000 at the American Society of Hematology meeting indicating that young adult ALL patients treated with the Children’s Cancer Group (CCG) protocol had significantly improved outcomes compared to those treated according to the adult Cancer and Leukemia Group B (CALGB) protocol. This abstract was one of the first pieces of research to highlight the differences in outcome utilizing a pediatric-like treatment plan for ALL in AYAs versus the traditional adult-type protocol. These initial findings were later expanded and confirmed in the 16–20 years age range, and the C10403 trial was developed. The intergroup trial combines the resources and reach of three of the NCI-sponsored cancer clinical trial cooperative groups— CALGB, the Eastern Oncology Cooperative Group (ECOG), and the Southwest Oncology Group (SWOG)—to test the hypothesis that increasing the eligible age limit for the successful Children’s Oncology Group (COG) AALL0232 protocol up to the age of 39 will continue to show improved outcomes for this group of patients. The study’s results will directly compare the outcomes of the intergroup trial participants to those on the COG trial. The young adult cancer movement needs increased AYA clinical trial participation to further understanding of these patients’ distinct differences and to support the rationale that AYAs need treatment and care that is more personalized for their age. JAYAO has now shown two examples of clinical trials that are available to AYAs through different mechanisms. While the C10403 trial offers a pediatric regimen through the adult cooperative groups, JAYAO’s first issue highlighted the expanded access of the COG AEWS1031 sarcoma trial to clinicians at non-COG institutions through the NCI’s Cancer Trials Support Unit (CTSU). We call everyone involved in the care of AYA cancer patients to encourage their institutions to participate in these clinical trials. There are important questions being asked and investigated, but we can only move forward in our understanding through increased enrollment of AYAs in these trials.