None listed
Conditions
Brief summary
The purpose of this study is to determine if an extended use of a chemotherapy medication (temozolomide) after radiation improves survival outcome in patients with newly diagnosed brain cancer (also called a glioblastoma). Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with a glioblastoma. Study details Participants will take part in one of two treatment options: - In treatment 1, participants will continue with their usual care. - In treatment 2, participants will receive an additional six cycles of chemotherapy for 5 days, with each cycle lasting 28 days. The treatment that participants receive will be decided randomly. Participants enrolled into treatment option 2 will undergo routine blood tests prior to the administration of chemotherapy as per their standard care It is hoped that this research will determine if temozolomide is effective in increasing the overall survival rates, as well as the duration of survival of participants with glioblastoma.
Interventions
The study will be comparing two standards of care, six versus 12 cycles of post-radiation temozolomide. Temozolomide is a DNA alkylating chemotherapy used in the treatment of glioblastoma.
Arm A: Will receive observation with standard clinical and radiological follow up
Arm B: Will receive an additional six cycles of post-radiation temozolomaide followed by observation with standard clinical and radiological follow up.
The dosage regimen of temozolomide is an oral capsule taken daily for five
The study will be comparing two standards of care, six versus 12 cycles of post-radiation temozolomide. Temozolomide is a DNA alkylating chemotherapy used in the treatment of glioblastoma. Arm A: Will receive observation with standard clinical and radiological follow up Arm B: Will receive an additional six cycles of post-radiation temozolomaide followed by observation with standard clinical and radiological follow up. The dosage regimen of temozolomide is an oral capsule taken daily for five consecutive days out of every 28 days, at the dose previously tolerated by the patient to a maximum of 200mg/m^2. Adherance will be monitored at four weekly clinical assessments
Sponsors
The Walter and Eliza Hall Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females with newly diagnosed, histologically confirmed glioblastoma 2. Adults, aged 18 years and over 3. Completed radiation plus concurrent temozolomide, followed by six cycles of post-radiation temozolomide 4. No evidence of progressive disease on on-study screening MRI. Residual disease or enhancement is allowed, as long as stability or response according to RANO criteria has been demonstrated compared with prior MRI 5. ECOG 0-2 6. Life expectancy of > 12 weeks 7. Fit for further temozolomide 8. Able to start study treatment within four weeks of day one of cycle six 9. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments 10. Signed, written informed consent.
Exclusion criteria
1. Progressive disease on on-study screening MRI according to RANO criteria when compared with prior MRI 2. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with the administration of study treatments or procedures 3. Other comorbidities or conditions that may compromise assessment of key outcomes 4. No temozolomide or cranial irradiation in the last five years prior to GBM diagnosis. 5. History of another malignancy within five years prior to registration. Patients with curatively treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or superficial transitional cell carcinoma of the bladder are eligible. 6. Significant infection, including chronic active hepatitis B, hepatitis C or HIV. 7. Concurrent illness, 8. Pregnancy, lactation, or inadequate contraception.
Outcome results
None listed