Hypofractionted radiation for Anaplastic Astrocytoma

Phase 2

• Conditions: Health Condition 1: C719- Malignant neoplasm of brain, unspecified

• Registration Number: CTRI/2021/11/037820
• Lead Sponsor: AIIMS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Age 18 - 65 years

Patients of either sex will be included

Karnofsky performance score 70 and above

Biopsy proven Anaplastic Astrocytoma (WHO grade III), 1p19q non-co deleted (IDH wt, ATRX retained or lost).

Baseline investigations [LFT, RFT, complete blood count] should be within normal limits Hemoglobin >10gm/dl, Platelet >100000, TLC-4000-11000

No history of prior anti-cancer treatment with radiotherapy, chemotherapy, or surgery

The patient must sign an informed consent before entry into the study

Exclusion Criteria

Age >65 years and <18 years

Unresectable disease

Previous history of neurosurgery or radiotherapy

Recurrent disease

Patients with significant co-morbid condition

History of previous malignancy

Karnofsky Performance score below 70

Not compliant for regular follow up

Spinal AA

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint <br/ ><br>i) Compare Progression free survival in hypo-fractionated to conventional radiotherapy at 2 years <br/ ><br>ii) Compare 2-year OS in hypo-fractionated to conventional radiotherapy <br/ ><br>Secondary endpoint <br/ ><br>i) To correlate neutrophil count, lymphocyte and CD4 count, AED with PFS and OS <br/ ><br>ii) To assess late treatment toxicity in both treatment armTimepoint: Primary endpoint <br/ ><br>i) Compare Progression free survival in hypo-fractionated to conventional radiotherapy at 2 years <br/ ><br>ii) Compare 2-year OS in hypo-fractionated to conventional radiotherapy <br/ ><br>Secondary endpoint <br/ ><br>i) To correlate neutrophil count, lymphocyte and CD4 count, AED with PFS and OS <br/ ><br>ii) To assess late treatment toxicity in both treatment arm

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint <br/ ><br>i) To correlate neutrophil count, lymphocyte and CD4 count, AED with PFS and OS <br/ ><br>ii) To assess late treatment toxicity in both treatment armTimepoint: Weekly