Glioblastomas Clinical Trial
Official title:
A Phase II Open Label Randomised Multicentric Study in Patients With Unresectable Glioblastoma Using Neo-adjuvant Treatment With Two Cycles of Temozolomide Previous Temozolomide Plus Radiation Therapy and Adjuvant Temozolomide vs. Neo-adjuvant Treatment With Two Cycles of Temozolomide Plus Bevacizumab Previous Temozolomide, Bevacizumab and Radiation Therapy and Adjuvant Temozolomide.
In the last 20 years, only temozolomide has obtained indication for the treatment of
High-grade glioma (HGG). Temozolomide during and later radiation therapy has doubled one
year survival and is the standard treatment for glioblastoma. But 30% of glioblastomas
receive only a biopsy as they can't be resected and don't get benefit from this treatment.
They and should be treated immediately after the biopsy to prevent neurological
deterioration but in spite of this approach they often deteriorate neurologically during
radiotherapy. . An effective pre-radiation treatment should improve their prognosis and
allow them to complete concomitant radiotherapy and temozolomide treatment. Bevacizumab in
recurrent HGG displays 63% of objective responses when combined with irinotecan. But
irinotecan is not the most active treatment in this disease.
We propose a phase II, two arms, open label, randomized, multicentric study with 2 cycles of
temozolomide before radiation therapy and concomitant temozolomide, in patients with
glioblastoma and 'biopsy-only'. Bevacizumab will be added to one arm.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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