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Impact of radiotherapy and radiotherapy technique on neurocognitive profile in grade 2 and 3 gliomas.

Prospective randomized study to evaluate the impact of radiotherapy and radiotherapy technique on neurocognitive profile in grade 2 and 3 gliomas. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069040
Enrollment
70
Registered
2024-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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: Hippocampus sparing volumetric modulated arc therapy.: one group will receive radiotherapy treatment with Hippocampus sparing volumetric modulated arc therapy, dose of 54Gy-60Gy at 2Gy

Sponsors

Post Graduate Institute of Medical Education and Research PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with infiltrative lower grade gliomas (grade 2-3) who have undergone tumor removal or at least biopsy with histopathologic confirmation. 2.Cranial radiotherapy is clinically indicated to prevent recurrence due to presence of high risk features (astrocytoma histology), subtotal resection (STR) or age older than 40 years. 3.Karnofsky Performance Status Scale score (KPS) more than or equal to 60. 4.No prior history of radiation to the brain. 5.No contraindications to contrast enhanced computed tomography (CECT) and contrast enhanced magnetic resonance imaging (CEMRI). 6.Routine blood parameters (Complete blood count (CBC), liver function test (LFT), kidney function test (KFT)) within normal limits. 7.Willing to give consent for the study.

Exclusion criteria

Exclusion criteria: 1)Any non malignant known CNS disease that can cause neurocognitive dysfunction. 2)Pregnant and lactating women. 3)Prior long term chemotherapy. 4)Moderate or severe neurocognitive dysfunction prior to radiotherapy (MMSE less than or equal to 18)

Design outcomes

Primary

MeasureTime frame
Change in neurocognitive functionTimepoint: pre radiotherapy treatment post radiotherapy treatment 3 months after radiotherapy treatment 6 months after radiotherapy treatment

Secondary

MeasureTime frame
Change in Depression, Anxiety & Stress Scale - 21 Items (DASS-21).Timepoint: Before radiotherapy treatment after radiotherapy treatment 3 months after radiotherapy treatment. 6 months after radiotherapy treatment.;Change in Quality of lifeTimepoint: Before radiotherapy treatment after radiotherapy treatment 3 months after radiotherapy treatment. 6 months after radiotherapy treatment.

Countries

India

Contacts

Public ContactDr Aditya Mehta

Post Graduate Institute of Medical Education and Research, (PGIMER), CHANDIGARH

drshikhagoyal@gmail.com8826136224

Outcome results

None listed

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