Neo-adjuvant Treatment With Temozolomide and Bevacizumab Previous to Temozolomide Plus Radiation Plus Bevacizumab Therapy in Unresectable Glioblastoma

Sponsor
Grupo Español de Investigación en Neurooncología
Study ID
NCT01102595
Phase
PHASE2
Status
Completed

Conditions

  • Glioblastomas

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Temozolomide — DRUG
    * 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.
  • Bevacizumab — DRUG
    * 2 cycles + bevacizumab 10 mg/kg every 15 days each two cycles. * Bevacizumab 10 mg/kg every 15 days, three dosis.
  • Standard radiation therapy — RADIATION
    42-49 days with standard radiation therapy (60 Gy): 2 Gy per day.

Study Details

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.

Key Dates

First listed
Apr 13, 2010
Start date
Dec 31, 2009
Status verified
Aug 2015
Primary completion
Oct 31, 2013
Completion
Dec 31, 2014

Study Design

Enrollment
102 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1: Temozolomide plus Radiation
    Group 1: Neoadjuvant phase: Temozolomide 85 mg/m2/d x 21 days every 28 days for 2 cycles. Adjuvant phase: Temozolomide 75 mg/m2/d x 42-49 days with standard radiation therapy (60 Gy). Maintenance phase: Temozolomide 150 - 200 mg/m2 d1-d5 q 28d for 6 cycles.
  • Experimental: 2: Temozolomide plus Radiation plus Bevacizumab
    Neoadjuvant phase: Temozolomide 85 mg/m2/d x 21 days every 28 days for 2 cycles + bevacizumab 10 mg/kg every 15 days. Adjuvant phase: Temozolomide 75 mg/m2/d x 42-49 days with standard radiation therapy (60 Gy) + bevacizumab 10 mg/kg every 15 days. Maintenance phase: Temozolomide 150 - 200 mg/m2 d1-d5 q 28d for 6 cycles.

Primary Outcome Measure

Response Rate [ Time Frame: Until the first 9 weeks of treatment ]

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