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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
* Temozolomide 85 mg/m2/d x 21 days every 28 days for 2 cycles. * Temozolomide 75 mg/m2/d x 42-49 days * Temozolomide 150 - 200 mg/m2 d1-d5 q 28d for 6 cycles.
* 2 cycles + bevacizumab 10 mg/kg every 15 days each two cycles. * Bevacizumab 10 mg/kg every 15 days, three dosis.
42-49 days with standard radiation therapy (60 Gy): 2 Gy per day.
Grupo Español de Investigacion en Neurooncologia
Madrid, Madrid, Spain
Response Rate
To determine differences in clinical activity in terms of objective response after 2 cycles of 4 weeks in both treatment arms in inoperable patients with glioblastoma (RANO criteria)
Time frame: Until the first 9 weeks of treatment
Percentage of patients who finish treatment
Time frame: 41 weeks
Progression-free survival
Time frame: the participants will be followed until disease progression by RANO criteria
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Assess the toxicity of the combination of the treatment. Temozolamide+bevacizumab+radiation Temozolamide+radiation After the inclusion of the first 10 patients treated with bevacizumab arm (arm 2)the inclusion will be temporarily interrupted until the last of these patients completed concomitant treatment (radiation, temozolomide, bevacizumab) to check the safety of treatment with analysis of adverse effects and toxicity. following the NCIC 3.0 criteria.
Time frame: 21 weeks
Percentage of patients without neurological deterioration before radiation therapy.
Time frame: 8 weeks
Overall survival
Time frame: Until death
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