Naive Unresectable Glioblastoma Clinical Trial
Official title:
Evaluation of the Irinotecan/Bevacizumab Association as Neo-adjuvant and Adjuvant Treatment of Chemoradiation With Temozolomide for Naive Unresectable Glioblastoma. Phase II Randomized Study With Comparison to Chemoradiation With Temozolomide
Treatment of glioblastoma (GBM) is based on surgery when possible, and chemoradiation with
temozolomide, which became a standard since the EORTC study (Stupp, 2005). However, the
prognosis of unresectable GBM remains poor despite chemoradiation with an estimated 10 month
median survival, in the range of the comparable patients in the RPA class V from the EORTC
study (Miramanoff, 2006).
Vredenburgh et al. from the Duke University (Durham, NC) reported at ASCO 2006 (fully
published in J Clin Oncol, 2007) a 57 % unexpected response rate using a
bevacizumab/irinotecan schedule in patients with relapsed GBM or grade 3 astrocytomas. This
unusual high response rate, sometimes with major and sustained responses, was confirmed by a
cooperative french study of ANOCEF (Guiu et al., 2008). Such a major improvement of
treatment effectiveness lead ANOCEF, which federates most of the active neuro-oncology teams
in France, to propose a neo-adjuvant and adjuvant bevacizumab-based chemotherapy framing a
standard temozolomide-based chemoradiation with the aim to improve the prognosis of
unresectable GBM.
The bevacizumab/temozolomide combination as neo-adjuvant is presently being evaluated by the
Duke University. We believe that an ambitious comparison of the
bevacizumab/irinotecan-schedule with the ''standard'' temozolomide-based chemoradiation is a
fascinating challenge to improve the treatment of this awful disease.
The ANOCEF proposal '' Evaluation of the irinotecan/bevacizumab association as neo-adjuvant
and adjuvant treatment of chemoradiation with temozolomide for naive unresectable
glioblastoma. Phase II randomized study with comparison to chemoradiation with
temozolomide'' has been successfully granted by INCA (Institut National du Fancer, France)
through its research program ( PHRC : Programme Hospitalier de Recherche Clinique).
Implementation of this program is now starting .
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment