Could skipping radiation help elderly brain cancer patients live longer with fewer side effects?
NCT ID NCT04765514
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether chemotherapy alone (temozolomide) works as well as the standard combination of chemotherapy plus radiation for elderly and frail patients with newly diagnosed glioblastoma. The study aims to enroll 107 patients aged 65 and older with poor performance status. If chemotherapy alone proves non-inferior, it could offer a less toxic and more convenient treatment option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Temozolomide (chemotherapy)
- What this could lead to
- If successful, this could show that chemotherapy alone is a safe and effective option for elderly glioblastoma patients, avoiding the added side effects of radiation.
- What could go wrong
- This is a small, early-phase trial (107 people) comparing two treatments, not testing a new drug. It may not prove that chemotherapy alone is better or equal, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 107 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Jun 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Newly-diagnosed, histologically proven, intracranial glioblastoma with maximal safe resection. Biopsy alone is expected if resection is not possible. MGMT promoter methylation status must be tested and the results positive (defined as all non-negative MGMT status, including intermediate or indeterminate status (i.e., with cutoff higher than the MGMT negative threshold). 2. History and physical examination, including neurological examination, within 14 days prior to randomization. 3. Age ≥ 65 \& KPS of 60 - 70 4. Stable or decreasing dose of corticosteroids for at least 14 days prior to randomization. 5. Laboratory evaluation within 7 days prior to randomization, with adequate function as defined below: 1. ANC ≥ 1.5 x 109/L 2. Platelets ≥ 100 x 109/L 3. Serum creatinine ≤ 1.5 times ULN or estimated Glomerular Filtration Rate (eGFR) \> 59 4. Total serum bilirubin ≤ 30 umol/L (ie ≤ 1.5 times ULN) 5. ALT \< 150 U/L (ie \< 3 times ULN) 6. AST \< 120 U/L (ie \< 3 times ULN) 7. Alkaline phosphatase \< 390 U/L (ie \< 3 times ULN) 6. Patients must sign a study-specific informed consent prior to study registration. 7. Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 6 months after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard. 1. This will apply for male patients only and their female partner if of child bearing potential. 2. Effective contraception should also be used by male patients taking temozolomide. Men being treated with temozolomide are advised not to father a child during or up to 6 months after discontinuation of treatment (male patients). 8. Male patients should agree to not donate sperm during the study treatment and for six months post treatment completion. Exclusion Criteria: 1. Negative MGMT promoter methylation status, or a status of not reportable. 2. Recurrent malignant gliomas 3. Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. 4. Prior head or neck RT (except for T1 glottic cancer), or systemic therapy precluding delivery of concurrent and adjuvant temozolomide 5. Treatment with any other therapeutic clinical protocol within 30 days prior to study registration or during participation in the study. 6. Severe, active co-morbidity, defined as follows: 1. Unstable angina and/or congestive heart failure requiring hospitalization 2. Transmural myocardial infarction within the last 6 months 3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study registration 4. Any severe, active co-morbidity precluding delivery of temozolomide. 5. History of hypersensitivity reaction to temozolomide components or to dacarbazine. 6. Active HBV infection
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Arthur J.E. Child Comprehensive Cancer Center (formerly Tom Baker Cancer Centre)
TERMINATEDCalgary, Alberta, Canada
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Cross Cancer Institute
RECRUITINGEdmonton, Alberta, T6G 1Z2, Canada
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