1/2/2008 SARC: An Effort to Perform Clinical Trials More Efficiently and Effectively for People with Sarcoma Robert Maki, MD, PhD Vice President, SARC Associate Member, Dept of Medicine Memorial Sloan-Kettering Cancer Center   There are a number of cooperative groups across the U.S. with an interest in improving the lot for people with metastatic cancer. These groups excel at performing large studies of people with common cancers, as has happened over the years in groups with an alphabet soup full of names such as ECOG, CALGB, NCCTG, SWOG, and ACOSOG, and the EORTC in Europe, for example. Cooperative groups have centralized data collection, a statistical center, and resources to insure the correct conduct of studies. Furthermore, in the United States, through a mechanism called the Clinical Trials Service Unit (CTSU), it is possible for these NCI-sponsored groups to involve more than one cooperative group in a given clinical study, further increasing the efficiency of the accrual and thus completion of the clinical trial. These cooperative groups have proven to be outstanding resources for the treatment of common cancer conditions.   In comparison to studies of more common diseases such as breast, colon, lung, or prostate cancer, there are not as many patients with sarcoma, so more investigators in more places are required to finish a study, the studies have to stay open longer, and the resulting cost per patient of conducting a study is higher per patient for sarcoma studies than for other diseases. Furthermore, radiologists and pathologists who follow patients with other cancers may not be as familiar with the metastatic patterns of sarcomas or their diagnosis, while having to deal with many other diseases. This same issue applies for the study of any rare disease.   A truly disease-specific group such as the Sarcoma Alliance for Research through Collaboration (SARC) may be a more efficient way to conduct clinical trials for this rare group of diseases. The nurses, surgeons, medical oncologists, pathologists, radiologists, and radiation therapists who take care of sarcoma patients on a regular basis understand how these varied tumors behave biologically, where they may travel and cause problems. They understand the complications of the therapies they routinely administer, which vary from nontoxic to very toxic. Sarcomas are all that many of these investigators think about, unfettered with, or at least less encumbered with the more common types of cancer, which typically overwhelm in number the patients with sarcoma in an oncologist's office.   While each investigator works hard on her/his own to conduct studies at their own site, SARC has engaged the most experienced investigators in the United States who treat sarcoma, and SARC members are seeking out colleagues in Europe and Australia on new projects. This collaborative effort provides the economy of scale that even cooperative groups may not be able to match, at least without an Intergroup (multiple cooperative group) study. Furthermore, SARC clinical trials are designed to both test new medications as well as use novel approaches to get to the correct answer faster than what one otherwise might. One good example is the SARC study of gemcitabine with or without docetaxel in people with metastatic sarcomas. Thanks to the design of the clinical trial (by Peter Thall and Kyle Wathen of the M.D. Anderson Cancer Center in Houston, TX), 20% more people were given the better treatment in the study than would have occurred otherwise by putting half of people on one treatment and half on the other. SARC is committed long term to using novel means to conduct their clinical studies.   SARC has clinical trials already open and new ones in the process of starting. A listing of those clinical trials is available on the SARC website and they can be searched through on the ClinicalTrials.gov website as well. More than a cooperative group, our goal is to lead a sarcoma-specific effort to new therapies for people with sarcomas in soft tissue and bone, in adults and children alike.