Phase III trial of hypo-fractionated accelerated intensity modulated radiotherapy with concurrent and maintenance temozolomide in newly diagnosed Glioblastoma (HYART-GBM)
Phase 3
- Conditions
- Health Condition 1: C719- Malignant neoplasm of brain, unspecified
- Registration Number
- CTRI/2020/06/025573
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Age >65 years and <18 years
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint <br/ ><br>i) To compare median overall survival between hypo-fractionated radiotherapy and conventional radiotherapy <br/ ><br>Secondary endpoint <br/ ><br>i) To compare PFS (Progression free survival) between hypo-fractionated radiotherapy and conventional radiotherapy <br/ ><br>ii) To assess the pattern of failure in both treatment arms <br/ ><br>iii) To assess late treatment toxicity in both treatment arms <br/ ><br>Timepoint: Primary endpoint <br/ ><br>i) To compare median overall survival between hypo-fractionated radiotherapy and conventional radiotherapy <br/ ><br>Secondary endpoint <br/ ><br>i) To compare PFS (Progression free survival) between hypo-fractionated radiotherapy and conventional radiotherapy <br/ ><br>ii) To assess the pattern of failure in both treatment arms <br/ ><br>iii) To assess late treatment toxicity in both treatment arms <br/ ><br>
- Secondary Outcome Measures
Name Time Method i) To compare PFS (Progression free survival) between hypo-fractionated radiotherapy and conventional radiotherapy <br/ ><br>ii) To assess the pattern of failure in both treatment arms <br/ ><br>iii) To assess late treatment toxicity in both treatment arms <br/ ><br>iv) To assess impact of pretreatment lymphocytopenia on outcome <br/ ><br>v) To assess impact of steroid use and anti-epileptic on outcome <br/ ><br>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 <br/ ><br>ii) Progression Free Survival (PFS) will be defined as the interval between surgery and date of documented (radiological) progression/ death