Health Condition 1: C719- Malignant neoplasm of brain, unspecified
Conditions
Interventions
Intervention1: Hypofractonated radiation: RT 60 Gy in 20 fractions over 4 weeks
Control Intervention1: Conventional RT: 60 Gy in 30 Fractions over 6 weeks
Sponsors
AIIMS
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) To compare PFS (Progression free survival) in hypo-fractionated radiotherapy to conventional radiotherapy ii) To compare 2-year OS in hypo-fractionated radiotherapy to conventional radiotherapy Secondary endpoint i) To correlate neutrophil count, lymphocyte and CD4 count with PFS and OS ii) To assess late treatment toxicity in both treatment armTimepoint: Primary endpoint i) To compare PFS (Progression free survival) in hypo-fractionated radiotherapy to conventional radiotherapy ii) To compare 2-year OS in hypo-fractionated radiotherapy to conventional radiotherapy Secondary endpoint i) To correlate neutrophil count, lymphocyte and CD4 count 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 with PFS and OS 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. ââ?¬Â¢ Overall Survival (OS) will be defined as the interval between surgery and date of death ââ?¬Â¢ 2-year Overall survival (OS) will be defined as percentage surviving at 3 year ââ?¬Â¢ Data will be censored at the last date of follow up. | — |
Countries
India
Contacts
Public ContactSupriya Mallick
NCI AIIMS New Delhi
Outcome results
None listed