Bentleigh East

Researchers are investigating treatment options for patients diagnosed with advanced non-small cell lung cancer NSCLC who have a poor prognosis with current therapies. This pilot study aims to evaluate the safety and feasibility of adding stereotactic ablative radiotherapy SABR to the lung tumor before standard systemic therapy in these patients. The study hopes to determine if radiotherapy to the primary lung tumor can be safely delivered before the third cycle of standard systemic therapy and whether this approach is feasible for a larger phase III trial. Participants will be randomly assigned to one of two groups one receiving standard of care SoC systemic therapy alone, and the other receiving radiotherapy to the lung primary tumor prior to the third cycle of SoC systemic therapy. Radiotherapy doses vary based on tumor size and location, and systemic therapy includes chemoimmunotherapy regimens such as Pembrolizumab combined with Carboplatin, Paclitaxel, or Pemetrexed depending on the cancer subtype. Biospecimens will be collected to support future research. During the study, participants will be monitored for radiation toxicity and adverse events through scheduled visits at baseline, radiotherapy if applicable, cycle 3 of systemic therapy, and at 12 and 24 weeks after starting treatment, as well as at disease progression. CT scans will be performed every six weeks to track disease status. The primary outcome is to assess the feasibility of delivering radiotherapy as planned, while secondary outcomes include patient willingness to be randomized, safety, and progression-free survival. The total recruitment period is 18 months, with follow-up extending to 24 months.

This research aims to evaluate the omission of adjuvant whole breast radiation therapy in women with breast cancer who have no clinical evidence of lymph node involvement and have achieved a pathological complete response after neoadjuvant chemotherapy. The study focuses on female patients with newly diagnosed T1-3 node negative breast cancer treated with breast conserving surgery and axillary staging surgery, without distant metastatic disease. The goal is to understand the impact of skipping radiation therapy on breast cancer outcomes. Participants will not receive the usual adjuvant whole breast radiation therapy following breast conserving surgery. Instead, they will be followed over time to monitor their health status. The study is designed as a single arm cohort, meaning all enrolled women who meet the criteria will be observed without receiving radiation therapy. The first analysis is planned after a median follow-up of 5 years. Throughout the study, participants will undergo regular assessments to check for local, regional, and distant recurrence of breast cancer, as well as disease-free survival and overall survival. Any additional breast cancer treatments received after recurrence, such as repeat surgery, systemic therapy, or radiation, will be documented. The total participation duration is planned to extend up to 5 years, with ongoing monitoring to measure outcomes and safety.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.