NCT01102595

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Grupo Español de Investigación en Neurooncología · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Glioblastomas

Interventions

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

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-10-01
• Completion: 2014-12-01
• First posted: 2010-04-13
• Last updated: 2015-08-26

Locations

1 site across 1 country: Spain