The EORTC 26081-22086 Codel trial was activated by the EORTC on 22 December 2010, the first patient was enrolled on 25 February 2011, and eleven patients have already been enrolled by EORTC institutions (one patient each in Austria and France, two in Belgium, and seven in the Netherlands). So far 24 patients with anaplastic oligodendroglioma or anaplastic mixed glioma have been enrolled by the activated sites in the United States and Europe. The targeted sample size for this trial is 585patients, 200 of whom are to be enrolled by EORTC institutions. Currently 17 sites have been activated: the side procedures in this trial, e.g. neurocognitive accreditation and quality assurance for radiotherapy, increase the complexity for site activation.
Large intergroup trials are essential in studies such as the Codel trial. The low incidence of rare tumors in the general population dictates that studies of these diseases establish broad international cooperation involving networks of experts with complementary areas of expertise. Only through international cooperation can we hope to make progress in rare tumors. Remarking on the enrolment, EORTC Director Denis Lacombe points out that “our efforts do pay off when we believe in projects. This brain tumor trial offers a paradigm for other rare tumor types, it being the largest academic transatlantic platform in an era of molecular based trials with integrated translational research.”
This Intergroup trial, a Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with Newly Diagnosed Anaplastic Oligodendroglioma or Anaplastic Mixed Glioma with Chromosomal Co-delections of 1p and 19q, is being coordinated by the North Central Cancer Treatment Group (NCCTG). The EORTC Study Coordinators are Wolfgang Wick, Universitaets Klinikum, Heidelberg , Martin J. van den Bent, Erasmus Medical Center, Rotterdam, and Frederic Dhermain , Institut Gustave Roussy, Villejuif.
The primary goal of the Codel trial is to determine if there is a survival advantage for those patients who receive concomitant temozolomide and radiotherapy followed by adjuvant temozolomide over that observed in patients treated with radiotherapy alone. It is thought that 1p and 19q loss of heterozygosity may be predictive of superior outcome for patients with anaplastic oligodendroglioma or anaplastic mixed glioma. However, it is not clear whether the 1p and 19q deletions simply represent a molecular signature reflecting a favorable natural biological behavior, or whether these markers are mechanistically related to response to therapy. The specific genes involved and the mechanism that results in improved outcome in patients with 1p/19q deletions need to be characterized.
EORTC, Medical Science Writer