Treatment of Bevacizumab Followed by Steroid in RN

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT04553510
Phase
PHASE2
Status
Unknown

Conditions

  • Adverse Effect of Radiation Therapy
  • Brain Injuries
  • Nasopharyngeal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab and steroid — DRUG
    Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential prednisone 10mg / d orally, the total course of 12 weeks.
  • Bevacizumab and placebo — DRUG
    Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential placebo 2 pills per day orally, the total course of 12 weeks.

Study Details

Treatment of bevacizumab followed by steroid may have a better effect on patients with radiation-induced brain injury.This randomized trial aims to investigate whether treatment of bevacizumab followed by steroid may alleviate radiation-induced brain injury in patients with nasopharyngeal carcinoma. The effect will be compared with outcomes in patients receiving steroid therapy

Key Dates

First listed
Sep 17, 2020
Start date
Jan 1, 2016
Status verified
Sep 2020
Primary completion
Dec 31, 2020
Completion
Jun 30, 2021

Study Design

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

Arms

  • Experimental: Bevacizumab and steroid
    Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential prednisone 10mg / d orally, the total course of 12 weeks.
  • Active Comparator: Bevacizumab and placebo
    Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential placebo 2 pills per day orally, the total course of 12 weeks.

Primary Outcome Measure

Change in magnetic resonance imaging (MRI) of radiation-induced brain necrosis in patients [ Time Frame: Change form baseline to evaluation at 12 weeks ]

Central Contacts

Related Studies