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

NCT01102595 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2015-08-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Grupo Español de Investigación en Neurooncología

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-10-31
Completion
2014-12-31

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01102595 on ClinicalTrials.gov