A Study of Low Dose Bevacizumab With Conventional Radiotherapy Alone in Diffuse Intrinsic Pontine Glioma

Sponsor
Tata Memorial Centre
Study ID
NCT04250064
Phase
PHASE2
Status
Recruiting
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Conditions

  • DIPG

Eligibility Criteria

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

Interventions

  • Bevacizumab Injection — DRUG
    Additional concurrent low-dose Bevacizumab with standard EBRT
  • Ultra-low-dose RT — RADIATION
    Ultra-low-dose EBRT instead of standard dose RT

Study Details

In this study, the investigators are testing improvement in survival outcomes in DIPG patients when stratified with MR perfusion score and treated with the said protocol. Newly diagnosed DIPG patients will undergo MRI perfusion study in addition to the usual MRI at diagnosis and will be stratified into hyperperfused or hypoperfused tumours. The hyperperfused patients will receive additional low dose Bevacizumab weekly with conventional standard radiotherapy. The hypo-perfused patients will receive ultra-low-dose radiotherapy fractionation equivalent to conventional RT biological dose.

Key Dates

First listed
Jan 31, 2020
Start date
Feb 4, 2020
Status verified
Apr 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Concurrent low-dose Bevacizumab
    Low-dose concurrent Bevacizumab with standard radiotherapy
  • Experimental: Ultra-low-dose RT
    Ultra-low-dose RT

Primary Outcome Measure

Overall Survival [ Time Frame: median of 12 months from diagnosis ]

Central Contacts

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