Phase III trial of hypo-fractionated accelerated intensity modulated radiotherapy with concurrent and maintenance temozolomide in newly diagnosed Glioblastoma (HYART-GBM)

Phase III trial of hypo-fractionated accelerated intensity modulated radiotherapy with concurrent and maintenance temozolomide in newly diagnosed Glioblastoma (HYART-GBM) - HYART-GBM

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025573

Enrollment

394

Registered

2020-06-03

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: This is a Phase III study comparing treatment outcome in newly diagnosed Glioblastoma patients treated with conventional fractionated radiotherapy to hypo-fr

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 - 65 years Patients of either sex will be included Karnofsky performance score 70 and above Biopsy proven Glioblastoma (WHO grade IV) 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 Previous history of nuero-surgery or radiotherapy Recurrent or metastatic disease Patients with significant co-morbid condition History of previous malignancy Performance score below 70 Unresectable disease Not compliant for regular follow up

Design outcomes

Primary

Measure	Time frame
Primary endpoint i) To compare median overall survival between hypo-fractionated radiotherapy and conventional radiotherapy Secondary endpoint i) To compare PFS (Progression free survival) between hypo-fractionated radiotherapy and conventional radiotherapy ii) To assess the pattern of failure in both treatment arms iii) To assess late treatment toxicity in both treatment arms Timepoint: Primary endpoint i) To compare median overall survival between hypo-fractionated radiotherapy and conventional radiotherapy Secondary endpoint i) To compare PFS (Progression free survival) between hypo-fractionated radiotherapy and conventional radiotherapy ii) To assess the pattern of failure in both treatment arms iii) To assess late treatment toxicity in both treatment arms	—

Measure

Time frame

Primary endpoint i) To compare median overall survival between hypo-fractionated radiotherapy and conventional radiotherapy Secondary endpoint i) To compare PFS (Progression free survival) between hypo-fractionated radiotherapy and conventional radiotherapy ii) To assess the pattern of failure in both treatment arms iii) To assess late treatment toxicity in both treatment arms Timepoint: Primary endpoint i) To compare median overall survival between hypo-fractionated radiotherapy and conventional radiotherapy Secondary endpoint i) To compare PFS (Progression free survival) between hypo-fractionated radiotherapy and conventional radiotherapy ii) To assess the pattern of failure in both treatment arms iii) To assess late treatment toxicity in both treatment arms

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Secondary

Measure	Time frame
i) To compare PFS (Progression free survival) between hypo-fractionated radiotherapy and conventional radiotherapy ii) To assess the pattern of failure in both treatment arms iii) To assess late treatment toxicity in both treatment arms iv) To assess impact of pretreatment lymphocytopenia on outcome v) To assess impact of steroid use and anti-epileptic on outcome vi) To Correlate IDH-1, MGMT, TERT, p53, and PTEN status with outcome in patients with newly diagnosed GlioblastomaTimepoint: i) Overall Survival (OS) will be defined as the interval between surgery and date of death ii) Progression Free Survival (PFS) will be defined as the interval between surgery and date of documented (radiological) progression/ death	—

Measure

Time frame

i) To compare PFS (Progression free survival) between hypo-fractionated radiotherapy and conventional radiotherapy ii) To assess the pattern of failure in both treatment arms iii) To assess late treatment toxicity in both treatment arms iv) To assess impact of pretreatment lymphocytopenia on outcome v) To assess impact of steroid use and anti-epileptic on outcome vi) To Correlate IDH-1, MGMT, TERT, p53, and PTEN status with outcome in patients with newly diagnosed GlioblastomaTimepoint: i) Overall Survival (OS) will be defined as the interval between surgery and date of death ii) Progression Free Survival (PFS) will be defined as the interval between surgery and date of documented (radiological) progression/ death

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Countries

India

Contacts

Public ContactDr Supriya Mallick

AIIMS, New Delhi

drsupriyamallick@gmail.com9910453489

Outcome results

None listed

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