Comparing Chemo-Radiotherapy with concurrent with Temozolomide monotherapy for glioblastoma multiforme
Official title: Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients
A Randomized Controlled Trial of Chemo-Radiotherapy Versus Chemotherapy for Elderly and Frail Patients With Newly Diagnosed Glioblastoma
Interventions
Temozolomide monotherapy
Temozolomide (TMZ) daily for 21 days, followed by up to 6 cycles of adjuvant TMZ, as tolerated. If tolerated, additional cycles of adjuvant TMZ may be administered.
Chemo-Radiotherapy with concurrent temozolomide.
Chemo-radiotherapy consisting of 40 Gy administered in 15 fractions on weekdays (Monday - Friday) concurrently with TMZ 75 mg/m2 daily for 21 days. This will be followed by up to 6 cycles of adjuvant TMZ (150-200 mg/m2 once daily on days 1-5 of a 28 day cycle), as tolerated. If tolerated, additional cycles of adjuvant TMZ may be administered at the treating investigator's discretion.
Canadian Sites (2)
Arthur J.E. Child Comprehensive Cancer Center (formerly Tom Baker Cancer Centre)
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Eligibility Criteria
See who this study is looking for30 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 65 \& KPS of 60 - 70
- +Serum creatinine ≤ 1.5 times ULN or estimated Glomerular Filtration Rate (eGFR) \> 59
- +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).
- +History and physical examination, including neurological examination, within 14 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +Stable or decreasing dose of corticosteroids for at least 14 days prior to randomization.
- +Laboratory evaluation within 7 days prior to randomization, with adequate function as defined below:
- +ANC ≥ 1.5 x 109/L
- +Platelets ≥ 100 x 109/L
- +Total serum bilirubin ≤ 30 umol/L (ie ≤ 1.5 times ULN)
- +ALT \< 150 U/L (ie \< 3 times ULN)
- +AST \< 120 U/L (ie \< 3 times ULN)
- +Alkaline phosphatase \< 390 U/L (ie \< 3 times ULN)
- +Patients must sign a study-specific informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → prior to study registration.
- +This will apply for male patients only and their female partner if of child bearing potential.
- +Male patients should agree to not donate sperm during the study treatment and for six months post treatment completion.
- +Patients of childbearing / reproductive potential should use highly effective birth controlControl groupThe group a new treatment is measured against.Read more → methods, as defined by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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.
- +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).
Exclusion
- −History of hypersensitivity reaction to temozolomide components or to dacarbazine.
- −Active HBV infection
- −Negative MGMT promoter methylation status, or a status of not reportable.
- −Recurrent malignant gliomas
- −Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years.
- −Prior head or neck RT (except for T1 glottic cancer), or systemic therapy precluding delivery of concurrent and adjuvant temozolomide
- −Treatment with any other therapeutic clinical protocolProtocolThe detailed plan a study must follow.Read more → within 30 days prior to study registration or during participation in the study.
- −Severe, active co-morbidity, defined as follows:
- −Unstable angina and/or congestive heart failure requiring hospitalization
- −Transmural myocardial infarction within the last 6 months
- −Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study registration
- −Any severe, active co-morbidity precluding delivery of temozolomide.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: Temozolomide monotherapy, Chemo-Radiotherapy with concurrent temozolomide.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 65 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 107 people.
The study is currently expected to finish around June 2032.
The main measurement is taken over: Through study completion, an average of 2 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Overall survival — measured over Through study completion, an average of 2 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04765514 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Temozolomide monotherapyOther
Temozolomide (TMZ) daily for 21 days, followed by up to 6 cycles of adjuvant TMZ, as tolerated. If tolerated, additional cycles of adjuvant TMZ may be administered.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Chemo-Radiotherapy with concurrent temozolomide.Combination product
Chemo-radiotherapy consisting of 40 Gy administered in 15 fractions on weekdays (Monday - Friday) concurrently with TMZ 75 mg/m2 daily for 21 days. This will be followed by up to 6 cycles of adjuvant TMZ (150-200 mg/m2 once daily on days 1-5 of a 28 day cycle), as tolerated. If tolerated, additional cycles of adjuvant TMZ may be administered at the treating investigator's discretion.
From the trial registry — its own words, unedited.
What a combination product is here: A product that combines two categories — for example a drug delivered by a device.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 65 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Through study completion, an average of 2 years..
The study as a whole is currently expected to finish around 2032-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 107 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Currently, the optimal treatment regimen for elderly Glioblastoma (GBM) patients with poor performance status (PS) is unknown. Based on data for elderly GBM patients and the limited data for patients with poor PS, hypofractionated RT or a short course of Temozolomide (TMZ) may provide survival benefit without the added toxicity and inconvenience of a more protracted treatment regimen. In particular, treatment with RT or TMZ monotherapy on the basis of methylated O6 - methyl guanine - DNA methyltransferase (MGMT) promoter methylation status, followed by the alternative therapy at progression, may provide a safe and effective treatment regimen for patients with poor PS. The hypothesis of this trial is that in elderly GBM patients with poor performance status (age ≥ 65 years and KPS 60-70), a chemotherapy alone (TMZ monotherapy) approach to therapy results in non-inferior overall survival compared to combined TMZ/RT. It is hypothesized that chemotherapy will result in non-inferior progression-free survival, reduced toxicity and increased cost-effectiveness compared to combined chemoradiotherapy. Primary objective: • To compare overall survival of standard therapy vs chemotherapy in elderly and frail patients with newly diagnosed GBM. Secondary objective: * To evaluate progression-free survival following treatment in both arms. * To evaluate adverse events according to CTCAE criteria in both arms. * To evaluate health-related quality-of-life as assessed by MoCA and EORTC QLQ-C30/QLQ-BN20 questionnaires in both arms. * To evaluate cost-effectiveness of standard therapy vs chemotherapy Methods: Patients will be randomized to two treatment groups in a 1:1 ratio. Standard Arm: Combined modality arm Chemo-radiotherapy consisting of 40 Gy in 15 daily fractions with concurrent TMZ. TMZ will be delivered at a dose of 75 mg/m2 daily for 21 days. TMZ will be administered 1 hour before each session of RT. After a 4-week break, patients will receive adjuvant TMZ according to the standard 5-day schedule (days 1-5) every 28 days, up to 6 cycles as tolerated by the patient. The dose will be 150 mg/m2 for the first cycle and increased to 200 mg/m2 beginning with the second cycle, so long as there are no hematologic adverse events, intractable nausea or fatigue. If tolerated, additional cycles of adjuvant TMZ may be administered at the treating investigator's discretion according to site practice. Investigational Arm: TMZ monotherapy Patients will receive TMZ at a dose of 75 mg/m2 daily for 21 days, followed by adjuvant TMZ according to the standard 5-day schedule (days 1-5) every 28 days, up to 6 cycles as tolerated by the patient. The dose will be 150 mg/m2 for the first cycle and increased to 200 mg/m2 beginning with the second cycle, so long as there are no hematologic adverse events, intractable nausea or fatigue. If tolerated, additional cycles of adjuvant TMZ may be administered at the treating investigator's discretion according to site practice. Upon treatment completion, participants will be followed by every 2 and 3 months for 2 years. Response and progression will be evaluated using the new international criteria proposed by the Response Assessment in Neuro-Oncology working group (RANO).
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.