Status:
RECRUITING
A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma
Lead Sponsor:
Tata Memorial Centre
Collaborating Sponsors:
Bhabha Atomic Research Centre (BARC)
Conditions:
Diffuse Glioma
Radionecrosis of Brain
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes d...
Detailed Description
Radiotherapy (RT) forms an integral role in the multi modality management of diffuse gliomas. Radiation is indicated in low-grade gliomas with high-risk features or high-grade gliomas following maxima...
Eligibility Criteria
Inclusion
- Histological diagnosis of diffuse glioma.
- Radionecrosis on imaging with new neurological symptoms/ worsening of prior deficits (Stratum A) or
- without new symptoms (Stratum B).
- Karnofsky Performance Scale (KPS) ≥ 50.
Exclusion
- No tissue diagnosis.
- KPS\< 50.
- Disease progression
- Contraindications to corticosteroids.
- Altered mental status with deficits in understanding or inability to consent to the study.
- Brainstem glioma
- Indeterminate for radionecrosis vs disease progression
- Prior treatment with bevacizumab (either for disease progression or radionecrosis)
Key Trial Info
Start Date :
November 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06016452
Start Date
November 13 2023
End Date
November 1 2025
Last Update
April 11 2025
Active Locations (1)
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1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012