๐ฌIn plain words
What the trial is, and whether it could suit you
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 โฅ 65 years and KPS 60-70), a chemotherapy alone (TMZ monotherapy) approach to therapy results in non-inferior overall survival
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ 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 โฅ 1.5 x 109/L
2. Platelets โฅ 100 x 109/L
3. Serum creatinine โค 1.5 times ULN or estimated Glomerular Filtration Rate (eGFR) \> 59
4. Total serum bilirubin โค 30 umol/L (ie โค 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 โฅ 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
๐
What it tests
- Temozolomide monotherapy
- Chemo-Radiotherapy with concurrent temozolomide.
Arthur J.E. Child Comprehensive Cancer Center (formerly Tom Baker Cancer Centre)
Calgary, Canada
Cross Cancer Institute
Edmonton, Canada
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.