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Compares treatment options for Glioblastoma Multiforme
Official title Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients
ClinicalTrials.gov ID: NCT04765514
What this study is testing
What is Chemo-Radiotherapy with concurrent temozolomide.?
Chemo-Radiotherapy with concurrent temozolomide. is an investigational medicine, given as an once-daily, being studied as a potential treatment for glioblastoma multiforme.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Newly-diagnosed, histologically proven, intracranial glioblastoma with maximal safe resection. Biopsy alone is expected if resection is not possible...
- History and physical examination, including neurological examination, within 14 days prior to randomization.
- Age ≥ 65 \& KPS of 60 - 70
- 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:
You likely can't join if
- 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 protocol within 30 days prior to study registration or during participation in the study.
- Severe, active co-morbidity, defined as follows:
See the full eligibility criteria
- 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...
- History and physical examination, including neurological examination, within 14 days prior to randomization.
- Age ≥ 65 \& KPS of 60 - 70
- 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
- Serum creatinine ≤ 1.5 times ULN or estimated Glomerular Filtration Rate (eGFR) \> 59
- 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 consent prior to study registration.
- 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...
- This will apply for male patients only and their female partner if of child bearing potential.
- 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...
- Male patients should agree to not donate sperm during the study treatment and for six months post treatment completion.
- 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 protocol 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.
- History of hypersensitivity reaction to temozolomide components or to dacarbazine.
- Active HBV infection
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.