Chemoradiotherapy Versus Biomarker-Guided Therapy for Elderly and Frail GBM Patients

Launched by AHS CANCER CONTROL ALBERTA · Feb 19, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring different treatment options for elderly patients (65 years and older) with a brain cancer called glioblastoma multiforme (GBM). Researchers want to find out if a "biomarker-guided" therapy, which tailors treatment based on specific genetic information about the tumor, is as effective as the standard combined approach of chemotherapy and radiation. Patients will be divided into two groups: one will receive a combination of chemotherapy (temozolomide) and radiation, while the other will receive treatment based on the tumor’s methylation status. Depending on this status, they will either take temozolomide alone or receive radiation therapy.

To participate in this trial, patients need to be newly diagnosed with GBM, have a certain level of physical ability (measured by their Karnofsky Performance Status), and meet other health criteria. Throughout the study, participants will receive regular check-ups to monitor their response to treatment and any side effects. The goal is to see if the biomarker-guided approach can improve survival rates while being less harmful and more cost-effective than the standard treatment. This trial is currently recruiting participants, and they will need to provide informed consent before joining.

Gender

MALE

Eligibility criteria

• 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 for all patients.
• • 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. 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. Recurrent malignant gliomas
• • 2. Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years.
• • 3. Prior head or neck RT (except for T1 glottic cancer), or systemic therapy precluding delivery of concurrent and adjuvant temozolomide
• • 4. Treatment with any other therapeutic clinical protocol within 30 days prior to study registration or during participation in the study.
• 5. 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