The EORTC is pleased to announce that SPECTAcolor, Screening Platform for Efficient Clinical Trial Access, has opened, and the first patients have enrolled. SPECTAcolor, the first Pan European collaborative molecular screening platform in colorectal cancer, will test molecular alterations in patients who are then screened for downstream biomarker-led clinical trials.
For this platform, adult patients with pathologically confirmed metastatic colorectal cancer (any N2; T4N1) with no more than two previous palliative lines of treatment are invited to give their informed consent to test for mutations in colorectal cancer biomarkers, i.e., in KRAS, BRAF, NRAS, MSI, and PI3K, of their primary tumor and/or the metastatic site(s) (FFPE tissue samples). In addition, circa 360 cancer genes will also be tested for research purposes using Next Generation Sequencing in cooperation with the Wellcome Trust Sanger Institute and used to further segregate these patients into disease subgroups.
Partnership with the EORTC PathoBiology Group and the European Society of Pathology (ESP) allows adoption of the best practices and standardized procedures for histopathology review and human biological material handling and biobanking. EORTC software will collect, trace, secure both data and samples.
Dr. Gunnar Folprecht of the Universitätsklinikum Carl Gustav Carus in Dresden and Coordinator of this project says, “A major bottleneck in introducing new cancer drugs to the market is the time it takes to complete clinical trials. Reducing the time needed to conduct cancer clinical trials would be an important achievement. Platforms such as EORTC are needed to gather patients via a pre-competitive route and optimize patient access to trials.”
Approximately 214.700 deaths are attributed to colorectal cancer per year making it the second most common cause of cancer related death in the Europe.
Prof. Sabine Tejpar of the Universitair Ziekenhuis Campus Gasthuisberg in Leuven and co-Coordinator of this project adds, “SPECTAcolor will facilitate the transformation of experimental discoveries into new treatments, have a significant clinical impact, and provide feedback from the clinic to the bench. It should be seen as a constantly evolving system with the ability to support new trials with innovative treatments.”
SPECTAcolor will be run initially in 25 sites located in ten countries: Belgium, Cyprus, France, Germany, Greece, Italy, Portugal, Spain, Sweden, and Switzerland. Between 600 and 1000 patients with stage III and IV colorectal cancer are expected to enroll each year.
Dr. Daniela Aust of the Universitätsklinikum Carl Gustav Carus in Dresden and co-Coordinator of this project says, “SPECTAcolor comprises a network of participating clinical sites and screening platforms that can screen each patient for multiple targets and potentially offer them access to trials with treatments against these targets. This study will improve our understanding of the disease biology, maximize expertise and quality assurance, and produce data not fragmented and sequestered within organizations.”
SPECTAcolor is a platform within a larger EORTC led partnership, SPECTAprogram, which includes other histologies. SPECTAprogram embraces as well the issues related to biomarker qualification and validation, hence addressing the challenges for developing companion tests (SPECTApath). SPECTAprogram can support new regulatory routes for adaptive licensing (SPECTAreg). SPECTAforum is an unprecedented place to meet for all stakeholders (patients, industry, researchers, physicians, regulators and payers) to develop and work out together new routes for drug development and registration, and structuring the path towards personalized medicine.
SPECTAcolor is supported by EORTC Charitable Trust and the corporate social responsibility program of Alliance Boots. The EORTC recognizes the European Society of Pathology and the Sanger Institute for their active and high quality contributions.
John Bean, PhD
EORTC Medical Science Writer