Hypofractionted radiation for Anaplastic Astrocytoma

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/037820

Enrollment

106

Registered

2021-11-03

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Hypofractionated radiation: Arm B: HFRT RT: 60 Gy/20Fractions/4weeks Oral TMZ 75mg/m2 D1-D28 Control Intervention1: conventional Radiation: CFRT RT: 60 Gy/30Fractions/6weeks OralTMZ 75m

Eligibility

Inclusion criteria

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

Exclusion criteria: Age >65 years and 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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Secondary endpoint i) To correlate neutrophil count, lymphocyte and CD4 count, AED with PFS and OS ii) To assess late treatment toxicity in both treatment armTimepoint: Weekly	—

Countries

India

Contacts

Public ContactSupriya Mallick

AIIMS, New Delhi

drsupriyamallick@gmail.com9910453489

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026