A CLINICAL TRIAL TO ASSESS THE ROLE OF CONCURRENT VALPROATE WITH CHEMORADIATION IN HIGH GRADE GLIOMA

CHEMORADIATION WITH AND WITHOUT CONCURRENT VALPROATE IN HIGH GRADE GLIOMA: A RANDOMISED CONTROLLED STUDY

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/08/015512

Enrollment

Registered

2018-08-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- HIGH GRADE GLIOMA (ANAPLASTIC ASTROCYTOMA GRADE III, GLIOBLASTOMA GRADE IV) Health Condition 2: C719- Malignant neoplasm of brain, unspecified

Interventions

Intervention1: ARM A: Patients receive treatment with 1. Conformal Radiotherapy 45Gy in 25 fractions over 5 weeks followed by Boost RT 14.4Gy in 8# over 1.5 weeks at 1.8Gy per fraction 2. Temozolomide

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed cases of high grade gliomas (Anaplastic Astrocytoma Grade III and Glioblastoma Grade IV) 2. KPS >60 3. Life expectancy >8 weeks 4. Adequate renal, hepatic andhematological function 5. Taking any anti epileptic except Valpraote as seizure prophylaxis 6. Willing to participate in study

Exclusion criteria

Exclusion criteria: 1. Previous history of use of Valproate or hypersensitivity to Valproate 2. Pregnancy 3. History of acute or chronic liver disease 4. Any history of comorbidities (Diabetes, Hypertension etc) not controlled on medication 5. Patients having second malignancy

Design outcomes

Primary

Measure	Time frame
1. PFS (RADIOLOGICAL PROGRESSION- tumor recurrence in patients with complete resection or increased contrast uptake by 25% or more in patients with incomplete resection or biopsy only compared to baseline for same lesion by same technique CLINICAL PROGRESSION- clinically deteriorating KPS, neurological function or increased corticosteroid dosage by 50% or more) 2. Response Rate as per RANO criteria 3. OS is time interval between randomisation and death due to any causeTimepoint: 1. PFS at 1 year 2. Response Rate at 3, 6 and 9 months	—

Measure

Time frame

1. PFS (RADIOLOGICAL PROGRESSION- tumor recurrence in patients with complete resection or increased contrast uptake by 25% or more in patients with incomplete resection or biopsy only compared to baseline for same lesion by same technique CLINICAL PROGRESSION- clinically deteriorating KPS, neurological function or increased corticosteroid dosage by 50% or more) 2. Response Rate as per RANO criteria 3. OS is time interval between randomisation and death due to any causeTimepoint: 1. PFS at 1 year 2. Response Rate at 3, 6 and 9 months

—

Secondary

Measure	Time frame
1. Quality of Life (QOL) 2. Recurrence pattern (CENTRAL RECURRENCE- recurrence between 100% to 95% isodose region INFIELD RECURRENCE-recurrence between 95% to 80% isodose region MARGINAL RECURRENCE-recurrence between 80% to 20% isodose region DISTANT RECURRENCE-recurrence beyond 20% isodose region)Timepoint: 1. QOL at 3,6,9,12 months	—

Countries

India

Contacts

Public ContactDr Treshita Dey

PGIMER, CHANDIGARH

treshita.dey@gmail.com8013528077

Outcome results

None listed

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