ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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2 results sorted by trial registration date.
  • A Randomised Phase II Study of NivolUmab and TeMozolomide vs Temozolomide alone in newly diagnosed Elderly patients with Glioblastoma (NUTMEG)

    This study aims to investigate effect of Nivolumab and Temozolomide vs Temozolomide alone on overall survival in newly diagnosed elderly patients with glioblastoma. Who is it for? You may be eligible to join this study if you are aged 65 years or above, with newly diagnosed histologically confirmed GBM (WHO grade IV glioma including gliosarcoma) following surgery. Study details Participants will be allocated to either experimental or control group in a 2:1 ratio by chance (randomly). Patients assigned to the experimental group will receive a course of nivolumab via intravenous infusion (240 mg on days 1 and 15 every 28 days for cycles 1-4; then 480 mg day 1 every 28 days for cycles 5-6) in addition to the standard regimen of Temozolomide (TMZ) tablets and radiotherapy. Patients assigned to the control group will receive the standard treatment of adjuvant temozolomide (150-200mg/m2 days 1-5 every 28 days) for 6 cycles and standard radiotherapy treatment (40 Gy administered in 15 fractions). The study aims to evaluate whether the combination of adjuvant nivolumab with temozolomide improves overall survival outcomes for this patient population. The outcome of the study will help determine the most effective treatment for patients with glioblastoma in the future.

  • A Phase II Study of Stereotactic Ablative Body Radiotherapy (SABR) for Stage I Non-Small Cell Lung Cancer (NSCLC)

    This study aims to investigate the efficacy of stereotactic ablative radiation therapy for treatment of Stage I non-small cell lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of Stage I non-small cell lung cancer. You must be able to lie flat and comply with the requirements of simulation and treatment. Participants in this study will be treated with stereotactic ablative radiation therapy with one of three dose and fractionation regimens. For peripheral lesions treatment dose will be 48 Gy in 4 fractions or 54 Gy in 3 fractions, depending on tumour size. For central lesions 50 Gy will be administered in 5 fractions. Overall treatment duration will vary from 11 – 14 days. Local control at 24 months is the primary endpoint of the study and is assessed by CT scans. Patients will be followed up until 5 years post treatment. A total of 100 patients will be recruited in this study.

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