1. 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
- Author
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Nicolas Magné, Georges Noël, Justine Attal, Guillaume Peyraga, Gilles Truc, Emmanuelle Uro-Coste, Muriel Mounier, Laure Vieillevigne, Anne Laprie, S. Ken, Valérie Bernier, Elizabeth Cohen-Jonathan Moyal, Carlos Gomez-Roca, F. Tensaouti, Muriel Poublanc, Jonathan Khalifa, Sergio Boetto, Stéphane Supiot, M. Charissoux, Vincent Lubrano, I. Catalaa, Amandine Fabre, Jean-Pierre Delord, Marie-Pierre Sunyach, and Thomas Filleron
- Subjects
Adult ,Diagnostic Imaging ,0301 basic medicine ,Cancer Research ,Magnetic Resonance Spectroscopy ,medicine.medical_treatment ,Perfusion scanning ,lcsh:RC254-282 ,Proton spectroscopy ,Study Protocol ,03 medical and health sciences ,Magnetic resonance spectroscopic imaging ,0302 clinical medicine ,Biopsy ,Temozolomide ,Genetics ,medicine ,Humans ,Prospective Studies ,External beam radiotherapy ,Antineoplastic Agents, Alkylating ,Spectroscopy ,medicine.diagnostic_test ,Radiotherapy ,Brain Neoplasms ,business.industry ,Phase III,online prospective quality control ,Radiotherapy Dosage ,Chemoradiotherapy ,Dose-painting ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Survival Analysis ,Clinical trial ,Radiation therapy ,030104 developmental biology ,Oncology ,030220 oncology & carcinogenesis ,Concomitant ,Radiotherapy, Intensity-Modulated ,Neoplasm Recurrence, Local ,business ,Nuclear medicine ,Glioblastoma ,medicine.drug - Abstract
Background Glioblastoma, a high-grade glial infiltrating tumor, is the most frequent malignant brain tumor in adults and carries a dismal prognosis. External beam radiotherapy (EBRT) increases overall survival but this is still low due to local relapses, mostly occurring in the irradiation field. As the ratio of spectra of choline/N acetyl aspartate> 2 (CNR2) on MR spectroscopic imaging has been described as predictive for the site of local relapse, we hypothesized that dose escalation on these regions would increase local control and hence global survival. Methods/design In this multicenter prospective phase III trial for newly diagnosed glioblastoma, 220 patients having undergone biopsy or surgery are planned for randomization to two arms. Arm A is the Stupp protocol (EBRT 60 Gy on contrast enhancement + 2 cm margin with concomitant temozolomide (TMZ) and 6 months of TMZ maintenance); Arm B is the same treatment with an additional simultaneous integrated boost of intensity-modulated radiotherapy (IMRT) of 72Gy/2.4Gy delivered on the MR spectroscopic imaging metabolic volumes of CHO/NAA > 2 and contrast-enhancing lesions or resection cavity. Stratification is performed on surgical and MGMT status. Discussion This is a dose-painting trial, i.e. delivery of heterogeneous dose guided by metabolic imaging. The principal endpoint is overall survival. An online prospective quality control of volumes and dose is performed in the experimental arm. The study will yield a large amount of longitudinal multimodal MR imaging data including planning CT, radiotherapy dosimetry, MR spectroscopic, diffusion and perfusion imaging. Trial registration NCT01507506, registration date December 20, 2011.
- Published
- 2019
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