Bevacizumab Alone Versus Dose-dense Temozolomide Followed by Bevacizumab for Recurrent Glioblastoma, Phase III

Sponsor
Kyorin University
Study ID
NCT02761070
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

Study Details

The aim of this Phase III study is to evaluate the superiority of dose-dense temozolomide (ddTMZ) followed by bevacizumab at ddTMZ failure for glioblastoma at first recurrence or progression, comparing to bevacizumab alone.

Key Dates

First listed
May 4, 2016
Start date
Jul 11, 2016
Status verified
Mar 2023
Primary completion
Nov 10, 2025
Completion
Nov 10, 2025

Study Design

Enrollment
146 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bevacizumab (BEV) alone
    Bevacizumab 10 mg/kg, day 1 div, every 2 weeks
  • Experimental: Dose Dense Temozolomide Followed by BEV
    Temozolomide (120 mg/m2, po, 7 days on/7 days off, every 2 weeks per cycle) up to 48 cycles. The dose will be escalated to 150 mg/m2 at 3rd cycle if the defined conditions are met throughout the first 2 cycles. At recurrence or progression, bevacizumab alone(10 mg/kg, day 1 div, every 2 weeks)

Primary Outcome Measure

Overall survival [ Time Frame: Time to event. Up to 2 years from the last patient in. ]

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