title: AVAglio: Phase 3 trial of bevacizumab plus temozolomide and radiotherapy in newly diagnosed glioblastoma multiforme.
abstract: Despite treatment with the current standard-of-care therapies, patients with newly diagnosed glioblastoma multiforme (GBM) exhibit dismal prognoses. Bevacizumab has demonstrated activity in patients with recurrent GBM and phase 2 trials indicate that the combination of bevacizumab with standard-of-care therapy is feasible and active for patients with newly diagnosed GBM. Bevacizumab has been granted US approval for use as single-agent therapy for patients with progressive GBM following prior therapy, although it has not received approval for use in patients with GBM in Europe. Phase 3 studies have been initiated in patients with newly diagnosed GBM and are currently recruiting patients. We describe the protocol for the AVAglio phase 3 registration trial, which is designed to evaluate the efficacy and safety of combining bevacizumab with standard-of-care therapy in patients with newly diagnosed GBM.
authors: Service de Neuro-Oncologie, Centre Hospitalo-Universitaire Timone, Université de la Méditerranée, Marseilles, France. olivier.chinot@ap-hm.fr
authors: O L
authors: OL
authors: Chinot
authors: T
authors: T
authors: de La Motte Rouge
authors: N
authors: N
authors: Moore
authors: A
authors: A
authors: Zeaiter
authors: A
authors: A
authors: Das
authors: H
authors: H
authors: Phillips
authors: Z
authors: Z
authors: Modrusan
authors: T
authors: T
authors: Cloughesy
mesh_terms: D000328:Adult; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000009:adverse effects; D000068258:Bevacizumab; D001932:Brain Neoplasms / Q000175:diagnosis / Q000628:therapy; D002985:Clinical Protocols; D017326:Clinical Trials, Phase III as Topic; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005060:Europe; D005909:Glioblastoma / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D011379:Prognosis; D011878:Radiotherapy; D012008:Recurrence; D059039:Standard of Care; D000077204:Temozolomide; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018906:Antineoplastic Agents, Alkylating; D000068258:Bevacizumab; D003606:Dacarbazine; D000077204:Temozolomide