Study comparing conventional radiotherapy vs stereotactic radiotherapy in GBM

A phase II randomized controlled study comparing post-operative stereotactic radiotherapy versus conventional radiotherapy along with concurrent and adjuvant temozolomide in patients with de novo glioblastoma - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076832

Enrollment

Registered

2024-11-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: C711- Malignant neoplasm of frontal lobe Health Condition 2: C714- Malignant neoplasm of occipital lobe Health Condition 3: C718- Malignant neoplasm of overlappingsites of brain Health Condition 4: C713- Malignant neoplasm of parietal lobe Health Condition 5: C712- Malignant neoplasm of temporal lobe

Interventions

Intervention1: Hypo fractionated stereotactic external beam radiotherapy 42Gy in 6 fractions with concurrent and adjuvant temozolomide: Hypo fractionated stereotactic external beam radiotherapy 42Gy i

Eligibility

Inclusion criteria

Inclusion criteria: Patients with histopathological confirmed diagnosis of GBM Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 Absence of uncontrolled medical comorbidity Normal organ function (Hb;10 g/dL, platelet count >;1 lakh/cu mm, creatinine clearance > 60 mL/sec, AST/ALT the normal range, serum bilirubin upper limit of the normal range)

Exclusion criteria

Exclusion criteria: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 3-4 Recurrent GBM Any previous history of cancer treatment including surgery, radiation, or chemotherapy Psychiatric condition or neurological co-morbidities with major cognitive function disorder Any uncontrolled comorbidity that may compromise the delivery of protocol-defined chemotherapy and radiotherapy e.g., renal disease, cardio-respiratory disease, diabetes mellitus Contraindications for CT/MRI imaging or contrast injection

Design outcomes

Primary

Measure	Time frame
To assess and compare the median overall survival between the experimental and conventional arm at 1 yearTimepoint: 1 year	—

Secondary

Measure	Time frame
To assess the treatment response rate after treatment completion in two arms.Timepoint: 3 and 6 months post treatment completion;To compare the progression-free survival in the 2 arms.Timepoint: 1 year;To compare the quality of life in the two armsTimepoint: Baseline, 1, 3 and 6 months post treatment completion;To assess and compare the caregiver burden related to patientsTimepoint: Baseline, 1 and 3 months post treatment completion;To assess and compare the impact on cognition in two treatment arms.Timepoint: 3 and 6 months post treatment completion;To assess and compare the incidence of grade 2 or worse acute toxicity profile in the 2 armsTimepoint: Weekly during radiotherapy and at 1 and 3 months	—

Measure

Time frame

To assess the treatment response rate after treatment completion in two arms.Timepoint: 3 and 6 months post treatment completion;To compare the progression-free survival in the 2 arms.Timepoint: 1 year;To compare the quality of life in the two armsTimepoint: Baseline, 1, 3 and 6 months post treatment completion;To assess and compare the caregiver burden related to patientsTimepoint: Baseline, 1 and 3 months post treatment completion;To assess and compare the impact on cognition in two treatment arms.Timepoint: 3 and 6 months post treatment completion;To assess and compare the incidence of grade 2 or worse acute toxicity profile in the 2 armsTimepoint: Weekly during radiotherapy and at 1 and 3 months

—

Countries

India

Contacts

Public ContactDr Anjali V R

All India Institute of Medical Sciences

dr.anjali.v.ramdulari@gmail.coM9446948374

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026