Actively Recruiting
A Study of Low Dose Bevacizumab With Conventional Radiotherapy Alone in Diffuse Intrinsic Pontine Glioma
Led by Tata Memorial Centre · Updated on 2025-04-11
40
Participants Needed
1
Research Sites
512 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Low Dose Bevacizumab With Conventional Radiotherapy Alone in Diffuse Intrinsic Pontine Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed treatment-nafve DIPG confirmed by clinical and radiographic findings
- Age between 3 and 18 years at diagnosis
- Karnofsky Performance Score (KPS) 50 for children over 12 years or Lansky Performance Score (LPS) 50 for children under 12 years
- Normal blood counts: neutrophils > 1,000/mcL, platelets > 100,000/mcL (without transfusion), hemoglobin > 8 gm/dL (transfusion allowed)
- Normal liver function: bilirubin < 1.5 times upper normal limit; ALT and AST < 5 times upper normal limit
- Normal kidney function: serum creatinine < 1.5 times upper normal limit or GFR > 70 ml/min/1.73m2; proteinuria less than 2 on morning urine dipstick
- Normal blood clotting profile
- Post-biopsy patients permitted if no brain hemorrhage larger than 0.5 cm and biopsy done 2-4 weeks before treatment start (for hyperperfused group)
- No contraindication for general anesthesia for MRI
- No need for general anesthesia for radiotherapy in hypofractionated group
- Parent or guardian willing to provide informed consent and child willing to assent as per policy
You will not qualify if you...
- Major surgery within 28 days before starting Bevacizumab or presence of serious/non-healing wounds
- Uncontrolled high blood pressure or proteinuria with urine protein/creatinine ratio ≥ 1.0
- History of deep venous or arterial thrombosis or known clotting disorders
- Allergic reactions to Chinese hamster ovary cell products or other recombinant human antibodies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Actively Recruiting
Research Team
R
Rahul Krishnatry, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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