imited fraction radiation in anaplastic astrocytoma

Phase 2

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

• Registration Number: CTRI/2021/08/035719
• 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) To compare PFS (Progression free survival) in hypo-fractionated radiotherapy to conventional radiotherapy <br/ ><br>ii) To compare 2-year OS in hypo-fractionated radiotherapy to conventional radiotherapy <br/ ><br>Secondary endpoint <br/ ><br>i) To correlate neutrophil count, lymphocyte and CD4 count with PFS and OS <br/ ><br>ii) To assess late treatment toxicity in both treatment armTimepoint: Primary endpoint <br/ ><br>i) To compare PFS (Progression free survival) in hypo-fractionated radiotherapy to conventional radiotherapy <br/ ><br>ii) To compare 2-year OS in hypo-fractionated radiotherapy to conventional radiotherapy <br/ ><br>Secondary endpoint <br/ ><br>i) To correlate neutrophil count, lymphocyte and CD4 count 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 with PFS and OS <br/ ><br>ii) To assess late treatment toxicity in both treatment armTimepoint: Progression Free Survival (PFS) will be defined as the interval between surgery and date of documented (radiological) progression. <br/ ><br>� Overall Survival (OS) will be defined as the interval between surgery and date of death <br/ ><br>� 2-year Overall survival (OS) will be defined as percentage surviving at 3 year <br/ ><br>� Data will be censored at the last date of follow up.