CTRI/2021/08/035719
Recruiting
Phase 2
Phase II study of hypo-fractionated accelerated radiotherapy with concurrent and maintenance temozolomide in newly diagnosed IDHwt Anaplastic Astrocytoma (NCI-R-01-HyRAA) - NCI-R-01-HyRAA
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: C719- Malignant neoplasm of brain, unspecified
- Sponsor
- AIIMS
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 \- 65 years
- •Ã¢â?¬Â¢ Patients of either sex will be included
- •Ã¢â?¬Â¢ Karnofsky performance score 70 and above
- •Ã¢â?¬Â¢ Biopsy proven Anaplastic Astrocytoma (WHO grade III), 1p19q non\-co deleted (IDH wt, ATRX retained or lost).
- •Ã¢â?¬Â¢ Baseline investigations \[LFT, RFT, complete blood count] should be within normal limits Hemoglobin \>10gm/dl, Platelet \>100000, TLC\-4000\-11000
- •Ã¢â?¬Â¢ No history of prior anti\-cancer treatment with radiotherapy, chemotherapy, or surgery
- •Ã¢â?¬Â¢ The patient must sign an informed consent before entry into the study
Exclusion Criteria
- •Age \>65 years and \<18 years
- •Ã¢â?¬Â¢ Unresectable disease
- •Ã¢â?¬Â¢ Previous history of neurosurgery or radiotherapy
- •Ã¢â?¬Â¢ Recurrent disease
- •Ã¢â?¬Â¢ Patients with significant co\-morbid condition
- •Ã¢â?¬Â¢ History of previous malignancy
- •Ã¢â?¬Â¢ Karnofsky Performance score below 70
- •Ã¢â?¬Â¢ Not compliant for regular follow up
- •Ã¢â?¬Â¢ Spinal AA
Outcomes
Primary Outcomes
Not specified
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