Trial comparing treatments 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?
An investigational combined chemo‑radiotherapy regimen being studied as a potential treatment for glioblastoma multiforme in elderly patients with poor performance status. It is designed to use radiation and temozolomide to damage the DNA of cancer cells, aiming to stop their growth.
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
- The study aims to see if chemotherapy alone gives similar overall survival to combined chemo‑radiotherapy, and to compare side effects, disease progression, quality of life, and cost.
- Who it's for
- People age 65 or older with newly diagnosed glioblastoma who have a low performance score (Karnofsky 60‑70).
- What's involved
- Participants are randomly assigned to receive either radiation plus temozolomide or temozolomide alone, followed by up to six cycles of temozolomide; they will have regular clinic visits, scans and questionnaires.
- Time commitment
- Treatment lasts about 6 months, with follow‑up visits every 2–3 months for up to 2 years.
- 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.