The ARCAD advanced colorectal cancer database—open for business
Authors: M. Buyse, D.J. Sargent, R.M. Goldberg, A. de Gramont
Journal: Annals of Oncology (2011)

The ARCAD Clinical Trials Program is a worldwide collaboration of clinicians, statisticians and scientists specializing in gastrointestinal malignancies [1.de Gramont A. Haller D.G. Sargent D.J. et al.Toward efficient trials in colorectal cancer: the ARCAD Clinical Trials Program.J Clin Oncol. 2010; 28: 527-530Crossref PubMed Scopus (15) Google Scholar]. The collaboration was launched in 2008 through the auspices of a French/USA charitable foundation, ARCAD (Aide et Recherche en Cancérologie Digestive) [2.Fondation ARCAD (Aide et Recherche en Cancérologie Digestive). http://www.fondationarcad.org (22 August 2010, date last accessed)Google Scholar]. The program's objective is to facilitate the development of more efficient clinical trials in gastrointestinal cancers through consensus recommendations and original research. Recently, we have completed construction of the ARCAD Advanced Colorectal Cancer Database, integrating patient-level data from most recent major trials in advanced colorectal cancer into a single resource. The database has been constructed at the Mayo Clinic (Rochester, MN) and will be mirrored at the International Drug Development Institute, Louvain-la-Neuve (Belgium) and GERCOR (Paris, France). The new database is similar to the GASTRIC and ACCENT databases developed for gastric and adjuvant colorectal cancer trials, respectively [3.Sargent D.J. Patiyil S. Yothers G. ACCENT Group et al.End points for colon cancer adjuvant trials: observations and recommendations based on individual patient data from 20,898 patients enrolled onto 18 randomized trials from the ACCENT Group.J Clin Oncol. 2007; 25: 4569-4574Crossref PubMed Scopus (208) Google Scholar,4.Paoletti X. Oba K. GASTRIC (Global Advanced/Adjuvant Stomach Tumor Research International Collaboration) Group et al.Benefit of adjuvant chemotherapy for resectable gastric cancer: a meta-analysis.JAMA. 2010; 303: 1729-1737Crossref PubMed Scopus (683) Google Scholar]. We now invite colleagues in the oncology research community to collaborate in the use of the database. The ARCAD Database currently integrates patient-level data from 24 large trials conducted over the past 12 years, with data from further trials pending. The dataset includes both academic and industry trials, across first, second and subsequent therapeutic lines. At present, data on over 18 000 individual patients have been incorporated, with data on several thousand further patients pending. We anticipate further expansion of the database as future trials are incorporated and thank academic and industry partners for their collaboration. The patient-level information recorded in the database includes baseline demographic, clinical and laboratory data, treatment regimens, time-specific tumor measurements and outcomes. The initial research projects carried out using the database will include analysis of trial end points, including progression-free survival and alternative short-term assessments; multi-line end points; assessment of baseline prognostic and predictive factors for response and outcome; assessment of RECIST criteria [5.Eisenhauer E.A. Therasse P. Bogaerts J. et al.New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).Eur J Cancer. 2009; 45: 228-247Abstract Full Text Full Text PDF PubMed Scopus (18123) Google Scholar] in advanced colorectal cancer; and construction of a 'trial simulator' to assist in planning of future studies. As with the ACCENT and GASTRIC databases, the sponsors of each contributed trial are consulted before every research project and may exclude their trial from an analysis if they consider it inappropriate. This measure is designed to uphold the interests of individual contributors. Moreover, in order to uphold patient confidentiality, no names or personal details of patients are recorded in the database. We now invite proposals for specific studies using the database from our colleagues in cancer research. Proposals will be reviewed by a panel of leading oncologists and statisticians drawn from the ARCAD membership. Groups with a potential interest in collaboration are requested to contact the principal investigators (DS, MB and AdG). We also welcome suggestions for further clinical trials to incorporate. Following the success of the colorectal cancer database, the ARCAD group has recently decided to launch a similar program in pancreatic cancer. We look forward to working with colleagues in many countries in the use of this important new resource. The authors declare no conflicts of interest.