Dose-painting multicenter phase III trial in newly diagnosed glioblastoma: the SPECTRO-GLIO trial comparing arm A standard radiochemotherapy to arm B radiochemotherapy with simultaneous integrated boost guided by MR spectroscopic imaging

• DOI: 10.1186/s12885-019-5317-x
• Publication Date: 2019-02-21T08:02:27Z
• Authors: Anne Laprie; Soléakhéna Ken; Thomas Filleron; Vincent Lubrano; Laure Vieillevigne; Fatima Tensaouti; Isabelle Catalaa; Sergio Boetto; Jonathan Khalifa; Justine Attal; Guillaume Peyraga; Carlos Gomez-Roca; Emmanuelle Uro-Coste; Georges Noel; Gilles Truc; Marie-Pierre Sunyach; Nicolas Magné; Marie Charissoux; Stéphane Supiot; Valérie Bernier; Muriel Mounier; Muriel Poublanc; Amandine Fabre; Jean-Pierre Delord; Elizabeth Cohen-J...
• Keywords: Temozolomide; External beam radiotherapy; Neuroradiology; Clinical endpoint

Glioblastoma, a high-grade glial infiltrating tumor, is the most frequent malignant brain tumor in adults and carries dismal prognosis. External beam radiotherapy (EBRT) increases overall survival but this still low due to local relapses, mostly occurring irradiation field. As ratio of spectra choline/N acetyl aspartate> 2 (CNR2) on MR spectroscopic imaging has been described as predictive for site relapse, we hypothesized that dose escalation these regions would increase control hence global survival. In multicenter prospective phase III trial newly diagnosed glioblastoma, 220 patients having undergone biopsy or surgery are planned randomization two arms. Arm A Stupp protocol (EBRT 60 Gy contrast enhancement + cm margin with concomitant temozolomide (TMZ) 6 months TMZ maintenance); B same treatment an additional simultaneous integrated boost intensity-modulated (IMRT) 72Gy/2.4Gy delivered metabolic volumes CHO/NAA > contrast-enhancing lesions resection cavity. Stratification performed surgical MGMT status. This dose-painting trial, i.e. delivery heterogeneous guided by imaging. The principal endpoint An online quality experimental arm. study will yield large amount longitudinal multimodal data including planning CT, dosimetry, spectroscopic, diffusion perfusion NCT01507506 , registration date December 20, 2011.