Glioblastoma (GBM)Phase 2ELITE-GBMNCT06835803
Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma: A Phase 2 Hybrid Randomized Trial
A Phase 2 study testing Dose-escalated radiation therapy and Standard hypofractionated radiation in people with Glioblastoma (GBM), run by Brigham and Women's Hospital at 3 sites in United States.
Trial summary
Glioblastoma (GBM) is an aggressive malignancy of the central nervous system. Older adults with GBM have a unique constellation of medical, psychosocial, and supportive care needs. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- Dose-escalated radiation therapy and Standard hypofractionated radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Apr 2025to 31 Mar 2029
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histological confirmation of WHO grade 4 glioblastoma (IDH wild-type by immunohistochemistry or sequencing). Histopathology must be confirmed by central review.
- Newly diagnosed disease, with time elapsed from diagnostic surgery/resection <8 weeks.
- Age ≥ 65 years old at time of glioblastoma diagnosis
- Adequate functional status as measured by a ECOG Performance Status 0, 1 or 2, at time of enrollment.
- Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 45 days prior to randomization:
- Platelet count ≥ 100 x 10^9/L (100,000 cells/mm^3) Serum creatinine ≤ 1.5 times the upper limit of normal Total serum bilirubin ≤ 1.5 times the upper limit of normal ALT (SGPT) < 2.5 times the upper limit of normal and/or AST (SGOT) < 2.5 times the upper limit of normal
- -Patient may have received corticosteroids, but must be on a stable or decreasing dose for at least 14 days prior to randomization.
Who cannot join
- Participants with recurrent glioma.
- Participants with evidence of spinal, leptomeningeal, or more distant disease.
- Participants with another active central nervous system malignancies requiring treatment.
- Participants with a second invasive malignancy that is A) incompletely treated or requiring ongoing treatment, or B) reasonably anticipated to be associated with a median overall survival of less than 1 year based on population-level data for the specified disease site and stage.
- Participants with any other major medical illnesses or psychiatric treatments that in the treating physician's opinion will prevent administration or completion of protocol therapy.
- Participants with inadequate mental capacity to provide informed consent
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- Participants who cannot receive gadolinium
- Participants who have undergone prior head and neck or cranial radiation or radiation to any other site previously that would be reasonably anticipated to result in a significant overlap in radiation fields.
- Participants who have received systemic or radiosensitizing therapy for a prior head and neck or central nervous system malignancy or any investigational cancer drug for glioblastoma prior to randomization.
- Participants who have received or plan to receive any other form of non-surgical local or field treatment overlapping with the anticipated radiation field.
- Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) or other acute medical conditions at the time of randomization that would impair the ability of the patient to receive protocol treatment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Rifaquat Rahman, MD, 6177325500, rrahman@bwh.harvard.edu
- Recruiting
Dana-Farber Brigham Cancer Center, Milford Hospital
Milford, Massachusetts, 01757
Monica Krishnan, MD, 5084883800, mkrishnan@bwh.harvard.edu
- Recruiting
Dana-Farber Brigham Cancer Center, South Shore Hospital
South Weymouth, Massachusetts, 02190
Anurag Saraf, MD, 7816244710, anurag_saraf@dfci.harvard.edu
About this study
Official title: Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma (ELITE-GBM): A Phase 2 Hybrid Randomized Trial Leveraging External Data
Glioblastoma (GBM) is an aggressive malignancy of the central nervous system. Older adults with GBM have a unique constellation of medical, psychosocial, and supportive care needs. To address these challenges, prior work has evaluated the feasibility of hypofractionation, a treatment approach delivering fewer, larger radiation dosages over a shorter time period. Common hypofractionated regimens deliver a lower biologically equivalent radiation dose than the conventional regimens used for younger adults. Whether dose escalated hypofractionation can further improve outcomes in older adults remains unclear.
This will be a hybrid randomized control trial comparing the efficacy and safety of dose-escalated and standard hypofractionated radiotherapy among older adults with newly-diagnosed glioblastoma compared to standard three-week course. This research study involves the administration of radiation therapy. Radiation will either be delivered at the standard daily dose or at an increased daily dose over a three weeks course of radiation treatment.
Read more
Research study procedures will include a screening evaluation to assess eligibility, as well as clinical visits for radiation delivery and to assess symptoms during treatment and at scheduled follow-up times.
Participants will be randomly assigned to one of the two arms of the trial:
- Standard hypofractionated radiation over 3 weeks
- Dose-escalated hypofractionated radiation over 3 weeks
- Conditions
- Glioblastoma (GBM)
- Being tested
- Dose-escalated radiation therapy, Standard hypofractionated radiation
- Keywords
- glioblastoma, elderly glioblastoma, hypofractionation
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose-escalated radiation therapyRadiation
Dose-escalated radiation therapy involves higher doses of radiation therapy each day of treatment over the three week course of radiation therapy
Standard hypofractionated radiationRadiation
Standard hypofractionated radiation therapy over 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dose-escalated hypofractionated radiation over 3 weeks | Experimental | Not described Receives: Radiation: Dose-escalated radiation therapy |
| Standard hypofractionated radiation over 3 weeks | Active comparator | Not described Receives: Radiation: Standard hypofractionated radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
through study completion, an average of 1 year
Measured: Overall survival from time of enrollment through study completion, an average of 1 year
Secondary outcomes (6)
Progression-free survival
Measured: Time of enrollment to time of progressionfrom time of enrollment through study completion, an average of 6 months
Treatment-related toxicity
Per CTCAE 5.0
Measured: Time of enrollment to end of treatment (upto 6 months after completion of radiation therapy)
Health-related quality of life
This will be measured by EORTC QLQ-C30 and QLQ-BN20 tools. Evaluation for changes in health-related quality of life by these instruments upto 6 months after radiation therapy.
Measured: From time of enrollment upto 6 months later
Mood symptoms
Measured by the Patient Health Questionnaire (PHQ-4). Evaluation of changes to PHQ-4 scores over time upto 6 months after radiation treatment.
Measured: From time of enrollment upto 6 months later
Practical Geriatric Assessment
Measured: From time of enrollment upto 6 months later
Performance status
Measured by Karnofsky Performance Status. Evaluation of changes of performance status over time upto 6 months after radiation treatment.
Measured: From time of enrollment upto 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start14 Apr 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will use a hybrid design that also leverages an external control dataset in order to adjust the randomization ratio in favor of the experimental arm.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rifaquat M. Rahman, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835803
- Sponsor's protocol ID
- 24-637
- Acronym
- ELITE-GBM
- Status last verified
- Sep 2025
- First submitted
- 7 Feb 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will plan to share IPD pending securing funding to facilitate data-sharing
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma (ELITE-GBM): A Phase 2 Hybrid Randomized Trial Leveraging External Data
- ClinicalTrials.gov ID
- NCT06835803
- Acronym / sponsor ID
- ELITE-GBM / 24-637
- Conditions
- Glioblastoma (GBM)
- Keywords
- glioblastoma, elderly glioblastoma, hypofractionation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 19 Feb 2025 (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.
Glioblastoma (GBM) is an aggressive malignancy of the central nervous system. Older adults with GBM have a unique constellation of medical, psychosocial, and supportive care needs. To address these challenges, prior work has evaluated the feasibility of hypofractionation, a treatment approach delivering fewer, larger radiation dosages over a shorter time period. Common hypofractionated regimens deliver a lower biologically equivalent radiation dose than the conventional regimens used for younger adults. Whether dose escalated hypofractionation can further improve outcomes in older adults remains unclear.
This will be a hybrid randomized control trial comparing the efficacy and safety of dose-escalated and standard hypofractionated radiotherapy among older adults with newly-diagnosed glioblastoma compared to standard three-week course. This research study involves the administration of radiation therapy. Radiation will either be delivered at the standard daily dose or at an increased daily dose over a three weeks course of radiation treatment.
Research study procedures will include a screening evaluation to assess eligibility, as well as clinical visits for radiation delivery and to assess symptoms during treatment and at scheduled follow-up times.
Participants will be randomly assigned to one of the two arms of the trial:
- Standard hypofractionated radiation over 3 weeks
- Dose-escalated hypofractionated radiation over 3 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will use a hybrid design that also leverages an external control dataset in order to adjust the randomization ratio in favor of the experimental arm.
| Arm | Type | Receives |
|---|---|---|
| Dose-escalated hypofractionated radiation over 3 weeks | Experimental | Radiation: Dose-escalated radiation therapy |
| Standard hypofractionated radiation over 3 weeks | Active comparator | Radiation: Standard hypofractionated radiation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Histological confirmation of WHO grade 4 glioblastoma (IDH wild-type by immunohistochemistry or sequencing). Histopathology must be confirmed by central review.
- Newly diagnosed disease, with time elapsed from diagnostic surgery/resection <8 weeks.
- Age ≥ 65 years old at time of glioblastoma diagnosis
- Adequate functional status as measured by a ECOG Performance Status 0, 1 or 2, at time of enrollment.
- Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 45 days prior to randomization:
Key exclusion criteria (11 listed)
- Participants with recurrent glioma.
- Participants with evidence of spinal, leptomeningeal, or more distant disease.
- Participants with another active central nervous system malignancies requiring treatment.
- Participants with a second invasive malignancy that is A) incompletely treated or requiring ongoing treatment, or B) reasonably anticipated to be associated with a median overall survival of less than 1 year based on population-level data for the specified disease site and stage.
- Participants with any other major medical illnesses or psychiatric treatments that in the treating physician's opinion will prevent administration or completion of protocol therapy.
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 |
|---|---|---|
| Dose-escalated radiation therapyDose-escalated radiation therapy involves higher doses of radiation therapy each day of treatment over the three week course of radiation therapy | Radiation | Dose-escalated hypofractionated radiation over 3 weeks |
| Standard hypofractionated radiationStandard hypofractionated radiation therapy over 3 weeks | Radiation | Standard hypofractionated radiation over 3 weeks |
Primary outcome
Overall survival
Time frame: Overall survival from time of enrollment through study completion, an average of 1 year
through study completion, an average of 1 year
6 secondary outcomes
Progression-free survival
Time frame: Time of enrollment to time of progressionfrom time of enrollment through study completion, an average of 6 months
Treatment-related toxicity
Time frame: Time of enrollment to end of treatment (upto 6 months after completion of radiation therapy)
Health-related quality of life
Time frame: From time of enrollment upto 6 months later
Mood symptoms
Time frame: From time of enrollment upto 6 months later
Practical Geriatric Assessment
Time frame: From time of enrollment upto 6 months later
Performance status
Time frame: From time of enrollment upto 6 months later
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 Sep 2025.
- Individual participant dataSharing planned: Undecided. We will plan to share IPD pending securing funding to facilitate data-sharing
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dose-escalated radiation therapy and Standard hypofractionated radiation in people with Glioblastoma (GBM), run by Brigham and Women's Hospital at 3 sites in United States.
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 7 inclusion and 11 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 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rifaquat Rahman, MD (617-732-6682, rrahman@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Overall survival from time of enrollment through study completion, an average of 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 Sep 2025.