Clinical trials have complex eligibility criteria.Always talk to your clinician about you’re interest in participating in a trial.Learn why
HP Version - Clinical trials have complex eligibility criteria.Always talk to your clinician about you’re interest in participating in a trial.Learn why
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Closed (no longer recruiting)Last updated: 19 February 2024
Clinical summaryEligibiltyParticipating hospitalsSupport
This trial is comparing two standards of care - 6 versus 12 cycles of post radiation temozolomide. Patients in Arm A of the trial will undergo observation with standard clinical and radiological follow up. Patients in Arm B will receive an additional 6 cycles of post-radiation temozolomide (orally) followed by observation with standard clinical and radiological follow up.
This trial is treating patients with glioblastoma.
Brain and Spinal
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Walter and Eliza Hall Institute
Phase III Trial of Extended Temozolomide in Newly Diagnosed Glioblastoma
Brain and spinal cord
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1. Males or females with newly diagnosed, histologically confirmed glioblastoma2. Adults, aged 18 years and over3. Completed radiation plus concurrent temozolomide, followed by six cycles of post-radiation temozolomide4. 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 MRI5. ECOG 0-26. Life expectancy of > 12 weeks7. Fit for further temozolomide8. Able to start study treatment within four weeks of day one of cycle six9. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments10. Signed, written informed consent.
1. Progressive disease on on-study screening MRI according to RANO criteria when compared with prior MRI2. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with the administration of study treatments or procedures3. Other comorbidities or conditions that may compromise assessment of key outcomes4. 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.
Clinical trials have complex eligibility criteria.
Ask your doctor if this trial could be right for you.
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