GliomaBIO-SHORTNCT07338539
BIO-SHORT: Hypofractionated RT for Poor-Prognosis GBM
A study testing Standard radiotherapy using hypofractionated RT and Experimental Arm Intervention in people with Glioma, run by Tata Memorial Centre at 1 site in India.
Trial summary
High grade gliomas, particularly glioblastoma, are among the most aggressive brain tumors and are associated with poor outcomes despite standard treatment. Many patients, especially older adults or those with poor general health, are not suitable for surgery and have a life expectancy of less than 12 months. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Standard radiotherapy using hypofractionated RT and Experimental Arm Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteIndia
- Study dates
- 6 Nov 2025to 27 Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biopsy proven IDH- wild type GBM or imaging defined GBM
- Neurological Predictor Scale (NPS) = 2-3
- Unfit for surgery and referred for direct RT
- Age >/= 50 years
Who cannot join
- IDH mutant glioma
- Histone altered glioma
- Multifocal disease or Gliomatosis like appearance which necessitates whole brain RT
- Disseminated disease in brain or spine
- NPS = 0-1 or = 4
- Karnofsky Performance Status score less than 50(Patient requires considerable assistance and frequent medical care)
- Prior administration of any systemic therapy directed against glioma (eg.Temozolomide, CCNU, Bevacizumab)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Abhishek Chatterjee, MD, 2224177000 ext. 6015, chatterji08@gmail.com
About this study
Official title: BIOlogically-guided Short-course HypOfractionatedRadiation Therapy in Poor-prognosis GBM (BIO-SHORT): A Prospective Phase 2 Randomised Control Trial
High grade gliomas, particularly glioblastoma, are among the most aggressive brain tumors and are associated with poor outcomes despite standard treatment. Many patients, especially older adults or those with poor general health, are not suitable for surgery and have a life expectancy of less than 12 months. Current standard includes a shortened course of radiotherapy (over 3 weeks) combined with chemotherapy using temozolomide (TMZ), which offers limited survival benefits. This study aims to explore whether delivering radiotherapy in a shorter duration (1 or 2 weeks) at a higher dose, guided by advanced imaging with a PET scan, can improve survival in this group of patients. PET scans help identify the most active parts of the tumor, which aids in targeting of these areas more precisely, potentially improving outcomes while reducing harm to healthy brain tissue. This study will randomly assign 116 eligible patients into two groups:
- One group will receive the current standard of care (3-week radiotherapy + TMZ).
- The other group will receive PET-guided radiotherapy over a shorter duration (either 5 or 10 sessions) at a higher dose, alongside TMZ.
The primary goal is to compare overall survival at one year between the two groups. The study will also assess how the disease progresses, side effects of treatment, and the impact on patients' quality of life. The study will be conducted over a total period of 6 years, including 4 years for patient enrolment and 2 years of follow-up. Participation in the study is entirely voluntary, and all patients will undergo an informed consent process. The study has been designed to follow all applicable ethical and regulatory guidelines. The results may help establish a more effective and convenient treatment option for patients with aggressive brain tumors and poor prognosis.
Read the detailed description
Introduction:
Glioblastoma Multiforme(GBM) is the most common malignant primary brain tumor which is uniformly fatal with dismal long term survival rates despite aggressive multimodality therapy. A large proportion of the patients are elderly, presenting at over 65 years of age and their treatment is associated with even more inferior outcomes. Treatment of such elderly patients with typical normo-fractionated Radiotherapy (RT) {1.8-2Gy per fractionation} over 6-6.5 weeks leads to unnecessary protraction of treatment, unduly encumbering patients and their caregivers. Randomised trials and subsequent meta-analyses have shown that hypo-fractionated RT ( typically delivered over 2 -3 weeks ) achieves similar survival as longer 6 week schedules in elderly patients in poor general condition. Addition of Temozolomide based chemotherapy was subsequently shown to improve survival and in current practice hypo-ractionated short course RT(hypo-RT) with TMZ represents the most optimal management of GBM in the elderly achieving a median survival in the vicinity of 6-9 months. Similar survival has been reported in institutional series in poor prognosis High Grade Glioma. Cumulatively, all the data serve as a relatively homogenous point for providing benchmark outcomes which may be used to improve survival by means of treatment intensification and optimisation of the HypoRT -TMZ backbone in this setting.
One of the most tangible ways in which outcomes can be improved pertains to the usage of a higher cumulative RT dose. Retrospective institutional data suggest that normo-fractionated schedules (59.4Gy/33#) delivered in fit elderly individuals are associated with survival benefit. Concurrent data shows that similar increase in median survival to 14-15 months is achievable by the usage of 3 week hypofractionated regimens which are iso-effective to the Stupp regimen. Further safe reduction to a 2 week schedule has been shown in a recent trial using proton therapy and Positron Emission Tomography (PET) guided sub-volume dose escalation. The reduction of dose to the normal brain has shown to be more pragmatically achievable in a recent trial incorporating reduced margins (5mm as opposed to 1.5 -2 cm) for microscopic disease and photon based fractionated radiosurgery which achieved a median survival of 14.8 months with no compromised survival due to marginal recurrences. Overall there is a need for a pragmatic trial incorporating an abbreviated schedule of photon based hypo-fractionated RT (5 fractions/10 fractions) in poor prognosis High Grade Glioma (HGG) using reduced margins and PET based biological sub-volume boosting to deliver adequate doses to the gross tumor and minimise surrounding normal brain RT doses to improve median benchmark survival to 14-15 months as compared to the prevailing standard of care (40Gy/15# with temozolomide). The current trial plans to address this knowledge gap.
Primary Endpoint:
The primary endpoint will be the Overall Survival (OS) at 1 year. Overall Survival will be defined as the time elapsed from the date of randomization to date of death due to any cause.
Secondary Endpoint:
- Progression Free Survival (PFS) at 1 year- Progression Free Survival will be defined as the time elapsed from the date of randomization to the date of clinico-radiological progression or death.
- Toxicity assessment with the NCI Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)
- Quality of life indices using the EORTC QLQC- 30 and its BN -20 module
- Quality of life without symptoms or toxicity in three health states TOX (toxicity), TWIST (time without symptoms) and REL (relapse)
Study Design:
The study will be a prospective, open-label2-arm Phase 2 randomized controlled trial with a superiority design. The standard arm will comprise of 3 week hypo-fractionated RT(40Gy/15#).The test arms will comprise of dose escalated hypo-fractionated RT (5 fractions/10 fractions). The usage of TMZ will be standard across both arms.
Study setting: The study will be conducted in the department of Radiation Oncology, Neuro Oncology Disease management group
- Conditions
- Glioma
- Being tested
- Standard radiotherapy using hypofractionated RT, Experimental Arm Intervention
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard radiotherapy using hypofractionated RTRadiation
Patients in the standard arm will undergo target volume delineation using conventional imaging. The initial clinical target volume (CTV-initial) will include the postoperative cavity, contrast-enhancing tumor on T1-weighted MRI, and gross disease. A 1-cm isotropic expansion, edited for anatomical barriers, will generate the CTV-final to account for infiltrative spread. The planning target volume (PTV) will be created using a 3-mm geometric margin for setup uncertainty. Radiotherapy will be delivered using photon-based image-guided IMRT, prescribed to a total dose of 40 Gy in 15 fractions, administered five days per week.
Experimental Arm InterventionRadiation
Patients in the experimental arm will undergo pretreatment evaluation, MRI-based simulation, and radiotherapy delivery similar to the standard arm, with the addition of pre-treatment F-DOPA PET imaging performed according to institutional consensus protocols. Biological target volumes (BTVs) will be delineated using a tumor-to-white-matter uptake ratio >2.0.
The initial clinical target volume (CTV-initial) will include the BTV, postoperative cavity, contrast-enhancing tumor on T1-weighted MRI, and gross disease. A 1.5-cm margin, edited for anatomical barriers, will generate the CTV-final to account for infiltrative spread. The planning target volume (PTV) will be created using a 3-5-mm geometric expansion.
Dose prescription will be based on PTV volume and location. Patients with PTV >30 cc or tumors not involving the brainstem will receive 40 Gy in 10 fractions to the BTV and 35 Gy in 10 fractions to the PTV. Those with PTV ≤30 cc or brainstem involvement will receive 30 Gy in 5 frac
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm | Active comparator | The standard arm will comprise of 3 week hypo-fractionated RT(40Gy/15#). Receives: Radiation: Standard radiotherapy using hypofractionated RT |
| Dose-escalated hypofractionated RT | Experimental | Patients in the experimental arm will undergo pretreatment evaluation, MRI-based simulation, and radiotherapy delivery similar to the standard arm, with the addition of pre-treatment F-DOPA PET imaging performed according to institutional consensus protocols. Biological target volumes (BTVs) will be delineated using a tumor-to-white-matter uptake ratio >2.0.
The initial clinical target volume (CTV-initial) will include the BTV, postoperative cavity, contrast-enhancing tumor on T1-weighted MRI, and gross disease. A 1.5-cm margin, edited for anatomical barriers, will generate the CTV-final to account for infiltrative spread. The planning target volume (PTV) will be created using a 3-5-mm geometric expansion.
Dose prescription will be based on PTV volume and location. Patients with PTV >30 cc or tumors not involving the brainstem will receive 40 Gy in 10 fractions to the BTV and 35 Gy in 10 fractions to the PTV. Those with PTV ≤30 cc or brainstem involvement will receive 30 Gy in 5 fra Receives: Radiation: Experimental Arm Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Outcomes
. Overall Survival will be defined as the time elapsed from the date of randomization to date of death due to any cause.
Measured: 1 year
Secondary outcomes (5)
Survival Outcome
Progression Free Survival (PFS) will be defined as the time elapsed fromthe date of randomization to the date of clinico-radiological progression or death.
Measured: 1 year
Quality of life indices- EORTC QLQC- 30
Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
The scale scores are linearly transformed to a range of 0 to 100. For functional scales and global health status, higher scores indicate better quality of life; for symptom scales, higher scores indicate worse symptoms. Assessed at baseline and follow-up.
Unit of Measure: Units on a scale
Measured: Baseline / Pre-radiotherapy, 4-6 weeks post-radiotherapy, 1 month, 3 months, 6 months, 9 months, and 12 months post-radiotherapy
Quality of life indices- EORTC BN20
Brain tumor-specific quality of life assessed using the European Organisation for Research and Treatment of Cancer Brain Neoplasm Module (EORTC QLQ-BN20).
Scores are transformed to a range of 0 to 100, where higher scores indicate greater symptom burden (worse outcome). Assessed at baseline and follow-up.
Unit of Measure: Units on a scale
Measured: Baseline / Pre-radiotherapy, 4-6 weeks post-radiotherapy, 1 month, 3 months, 6 months, 9 months, and 12 months post-radiotherapy
QTWiST (Quality of life Without Symptoms or Toxicity) calculation
QTWiST (Quality-Adjusted Time Without Symptoms or Toxicity) will be calculated by partitioning overall survival time into three mutually exclusive health states:
TOX (time with treatment-related toxicity), TWiST (time without symptoms or toxicity), and REL (time after relapse/progression).
The QTWiST value will be derived by applying utility weights to each health state and summing the weighted time spent in each state, expressed in months of quality-adjusted survival. Assessed at 3 months.
Unit of Measure: Months (quality-adjusted survival time)
Measured: will be done at 3 months
Toxicity Assessment
Toxicity assessment with the NCI Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)- Grade 1-5
Measured: Baseline / Pre-radiotherapy, 4-6 weeks post-radiotherapy, 1 month, 3 months, 6 months, 9 months, and 12 months post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start6 Nov 2025
- Primary completion27 Oct 2031 (estimated)
- Study completion27 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a prospective, open-label, 2-arm, Phase 2 randomised controlled trial with a superiority design. The standard arm will comprise of 3 week hypo-fractionated RT(40Gy/15#).The test arms will comprise of dose escalated hypo-fractionated RT (5 fractions/10 fractions). The usage of TMZ will be standard across both arms.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338539
- Sponsor's protocol ID
- 4840
- Acronym
- BIO-SHORT
- Status last verified
- May 2026
- First submitted
- 24 Nov 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOlogically-guided Short-course HypOfractionatedRadiation Therapy in Poor-prognosis GBM (BIO-SHORT): A Prospective Phase 2 Randomised Control Trial
- ClinicalTrials.gov ID
- NCT07338539
- Acronym / sponsor ID
- BIO-SHORT / 4840
- Conditions
- Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 27 Oct 2031 (estimated)
- Study completion
- 27 Oct 2031 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High grade gliomas, particularly glioblastoma, are among the most aggressive brain tumors and are associated with poor outcomes despite standard treatment. Many patients, especially older adults or those with poor general health, are not suitable for surgery and have a life expectancy of less than 12 months. Current standard includes a shortened course of radiotherapy (over 3 weeks) combined with chemotherapy using temozolomide (TMZ), which offers limited survival benefits. This study aims to explore whether delivering radiotherapy in a shorter duration (1 or 2 weeks) at a higher dose, guided by advanced imaging with a PET scan, can improve survival in this group of patients. PET scans help identify the most active parts of the tumor, which aids in targeting of these areas more precisely, potentially improving outcomes while reducing harm to healthy brain tissue. This study will randomly assign 116 eligible patients into two groups:
- One group will receive the current standard of care (3-week radiotherapy + TMZ).
- The other group will receive PET-guided radiotherapy over a shorter duration (either 5 or 10 sessions) at a higher dose, alongside TMZ.
The primary goal is to compare overall survival at one year between the two groups. The study will also assess how the disease progresses, side effects of treatment, and the impact on patients' quality of life. The study will be conducted over a total period of 6 years, including 4 years for patient enrolment and 2 years of follow-up. Participation in the study is entirely voluntary, and all patients will undergo an informed consent process. The study has been designed to follow all applicable ethical and regulatory guidelines. The results may help establish a more effective and convenient treatment option for patients with aggressive brain tumors and poor prognosis.
Detailed description
Introduction:
Glioblastoma Multiforme(GBM) is the most common malignant primary brain tumor which is uniformly fatal with dismal long term survival rates despite aggressive multimodality therapy. A large proportion of the patients are elderly, presenting at over 65 years of age and their treatment is associated with even more inferior outcomes. Treatment of such elderly patients with typical normo-fractionated Radiotherapy (RT) {1.8-2Gy per fractionation} over 6-6.5 weeks leads to unnecessary protraction of treatment, unduly encumbering patients and their caregivers. Randomised trials and subsequent meta-analyses have shown that hypo-fractionated RT ( typically delivered over 2 -3 weeks ) achieves similar survival as longer 6 week schedules in elderly patients in poor general condition. Addition of Temozolomide based chemotherapy was subsequently shown to improve survival and in current practice hypo-ractionated short course RT(hypo-RT) with TMZ represents the most optimal management of GBM in the elderly achieving a median survival in the vicinity of 6-9 months. Similar survival has been reported in institutional series in poor prognosis High Grade Glioma. Cumulatively, all the data serve as a relatively homogenous point for providing benchmark outcomes which may be used to improve survival by means of treatment intensification and optimisation of the HypoRT -TMZ backbone in this setting.
One of the most tangible ways in which outcomes can be improved pertains to the usage of a higher cumulative RT dose. Retrospective institutional data suggest that normo-fractionated schedules (59.4Gy/33#) delivered in fit elderly individuals are associated with survival benefit. Concurrent data shows that similar increase in median survival to 14-15 months is achievable by the usage of 3 week hypofractionated regimens which are iso-effective to the Stupp regimen. Further safe reduction to a 2 week schedule has been shown in a recent trial using proton therapy and Positron Emission Tomography (PET) guided sub-volume dose escalation. The reduction of dose to the normal brain has shown to be more pragmatically achievable in a recent trial incorporating reduced margins (5mm as opposed to 1.5 -2 cm) for microscopic disease and photon based fractionated radiosurgery which achieved a median survival of 14.8 months with no compromised survival due to marginal recurrences. Overall there is a need for a pragmatic trial incorporating an abbreviated schedule of photon based hypo-fractionated RT (5 fractions/10 fractions) in poor prognosis High Grade Glioma (HGG) using reduced margins and PET based biological sub-volume boosting to deliver adequate doses to the gross tumor and minimise surrounding normal brain RT doses to improve median benchmark survival to 14-15 months as compared to the prevailing standard of care (40Gy/15# with temozolomide). The current trial plans to address this knowledge gap.
Primary Endpoint:
The primary endpoint will be the Overall Survival (OS) at 1 year. Overall Survival will be defined as the time elapsed from the date of randomization to date of death due to any cause.
Secondary Endpoint:
- Progression Free Survival (PFS) at 1 year- Progression Free Survival will be defined as the time elapsed from the date of randomization to the date of clinico-radiological progression or death.
- Toxicity assessment with the NCI Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)
- Quality of life indices using the EORTC QLQC- 30 and its BN -20 module
- Quality of life without symptoms or toxicity in three health states TOX (toxicity), TWIST (time without symptoms) and REL (relapse)
Study Design:
The study will be a prospective, open-label2-arm Phase 2 randomized controlled trial with a superiority design. The standard arm will comprise of 3 week hypo-fractionated RT(40Gy/15#).The test arms will comprise of dose escalated hypo-fractionated RT (5 fractions/10 fractions). The usage of TMZ will be standard across both arms.
Study setting: The study will be conducted in the department of Radiation Oncology, Neuro Oncology Disease management group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will be a prospective, open-label, 2-arm, Phase 2 randomised controlled trial with a superiority design. The standard arm will comprise of 3 week hypo-fractionated RT(40Gy/15#).The test arms will comprise of dose escalated hypo-fractionated RT (5 fractions/10 fractions). The usage of TMZ will be standard across both arms.
| Arm | Type | Receives |
|---|---|---|
| Standard Arm | Active comparator | Radiation: Standard radiotherapy using hypofractionated RTThe standard arm will comprise of 3 week hypo-fractionated RT(40Gy/15#). |
| Dose-escalated hypofractionated RT | Experimental | Radiation: Experimental Arm InterventionPatients in the experimental arm will undergo pretreatment evaluation, MRI-based simulation, and radiotherapy delivery similar to the standard arm, with the addition of pre-treatment F-DOPA PET imaging performed according to institutional consensus protocols. Biological target volumes (BTVs) will be delineated using a tumor-to-white-matter uptake ratio >2.0. The initial clinical target volume (CTV-initial) will include the BTV, postoperative cavity, contrast-enhancing tumor on T1-weighted MRI, and gross disease. A 1.5-cm margin, edited for anatomical barriers, will generate the CTV-final to account for infiltrative spread. The planning target volume (PTV) will be created using a 3-5-mm geometric expansion. Dose prescription will be based on PTV volume and location. Patients with PTV >30 cc or tumors not involving the brainstem will receive 40 Gy in 10 fractions to the BTV and 35 Gy in 10 fractions to the PTV. Those with PTV ≤30 cc or brainstem involvement will receive 30 Gy in 5 fra |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with biopsy proven IDH- wild type GBM or imaging defined GBM
- Neurological Predictor Scale (NPS) = 2-3
- Unfit for surgery and referred for direct RT
- Age >/= 50 years
Key exclusion criteria (7 listed)
- IDH mutant glioma
- Histone altered glioma
- Multifocal disease or Gliomatosis like appearance which necessitates whole brain RT
- Disseminated disease in brain or spine
- NPS = 0-1 or = 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard radiotherapy using hypofractionated RTPatients in the standard arm will undergo target volume delineation using conventional imaging. The initial clinical target volume (CTV-initial) will include the postoperative cavity, contrast-enhancing tumor on T1-weighted MRI, and gross disease. A 1-cm isotropic expansion, edited for anatomical barriers, will generate the CTV-final to account for infiltrative spread. The planning target volume (PTV) will be created using a 3-mm geometric margin for setup uncertainty. Radiotherapy will be delivered using photon-based image-guided IMRT, prescribed to a total dose of 40 Gy in 15 fractions, administered five days per week. | Radiation | Standard Arm |
| Experimental Arm InterventionPatients in the experimental arm will undergo pretreatment evaluation, MRI-based simulation, and radiotherapy delivery similar to the standard arm, with the addition of pre-treatment F-DOPA PET imaging performed according to institutional consensus protocols. Biological target volumes (BTVs) will be delineated using a tumor-to-white-matter uptake ratio >2.0. The initial clinical target volume (CTV-initial) will include the BTV, postoperative cavity, contrast-enhancing tumor on T1-weighted MRI, and gross disease. A 1.5-cm margin, edited for anatomical barriers, will generate the CTV-final to account for infiltrative spread. The planning target volume (PTV) will be created using a 3-5-mm geometric expansion. Dose prescription will be based on PTV volume and location. Patients with PTV >30 cc or tumors not involving the brainstem will receive 40 Gy in 10 fractions to the BTV and 35 Gy in 10 fractions to the PTV. Those with PTV ≤30 cc or brainstem involvement will receive 30 Gy in 5 frac | Radiation | Dose-escalated hypofractionated RT |
Primary outcome
Survival Outcomes
Time frame: 1 year
. Overall Survival will be defined as the time elapsed from the date of randomization to date of death due to any cause.
5 secondary outcomes
Survival Outcome
Time frame: 1 year
Quality of life indices- EORTC QLQC- 30
Time frame: Baseline / Pre-radiotherapy, 4-6 weeks post-radiotherapy, 1 month, 3 months, 6 months, 9 months, and 12 months post-radiotherapy
Quality of life indices- EORTC BN20
Time frame: Baseline / Pre-radiotherapy, 4-6 weeks post-radiotherapy, 1 month, 3 months, 6 months, 9 months, and 12 months post-radiotherapy
QTWiST (Quality of life Without Symptoms or Toxicity) calculation
Time frame: will be done at 3 months
Toxicity Assessment
Time frame: Baseline / Pre-radiotherapy, 4-6 weeks post-radiotherapy, 1 month, 3 months, 6 months, 9 months, and 12 months post-radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard radiotherapy using hypofractionated RT and Experimental Arm Intervention in people with Glioma, run by Tata Memorial Centre at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abhishek Chatterjee, MD (2224177000 ext. Ext. 6015, chatterji08@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Outcomes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.