Low-dose Bevacizumab With HSRT vs BVZ Alone for GBM at First Recurrence

Sponsor
Huashan Hospital
Study ID
NCT05611645
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Hypofractionated Stereotactic Radiotherapy — RADIATION
    Starting with low-dose bevacizumab, 25Gy in 5 fractions of 5 Gy each delivered on consecutive treatment days.
  • Bevacizumab — DRUG
    Staring within 2 weeks of randomization, IV 5mg/kg (experimental group) or 10mg/kg (comparison group) every two weeks until disease progression.

Study Details

This randomized phase II trial studies how well lose dose bevacizumab with Hypofractionated Stereotactic Radiotherapy (HSRT) works versus bevacizumab alone in treating patients with glioblastoma at first recurrence. The primary endpoint is 6-month progress-free survivaloverall survival after the treatment. Secondary endpoints included overall survival, objective response rate, cognitive function, quality of life and toxicity.

Key Dates

First listed
Nov 10, 2022
Start date
Oct 1, 2022
Status verified
Nov 2022
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: HSRT+Low-dose Bevacizumab
    HSRT with low-dose bevacizumab every 2 weeks
  • Active Comparator: Bevacizumab
    Bevacizumab every 2 weeks

Primary Outcome Measure

Progression-free Survival rate at 6 Months [ Time Frame: From randomization to six months ]

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