Sondrio

Researchers are evaluating whether tucatinib combined with trastuzumab and mFOLFOX6 works better than the standard treatments for people with HER2 positive metastatic colorectal cancer, which is cancer that has spread or cannot be removed by surgery. This phase 3 study also aims to identify the side effects that may occur with this drug combination. Participants must have HER2 positive disease confirmed by testing and measurable cancer according to specific criteria. Participants will be randomly assigned to one of two groups. One group will receive tucatinib taken orally twice daily along with intravenous trastuzumab and the mFOLFOX6 chemotherapy regimen, which includes oxaliplatin, leucovorin or levoleucovorin, and fluorouracil given by IV every two weeks. The other group will receive standard care, which could be mFOLFOX6 alone or combined with either bevacizumab or cetuximab, both given by IV on specific schedules. Treatment continues as per the study protocol. During the study, participants will be monitored for progression-free survival up to about three years using imaging reviewed by independent experts. Researchers will assess side effects and disease response. Participants must be able to provide tumor tissue samples for testing and have a good performance status. The study includes brain imaging to check for metastases and monitors safety closely throughout the treatment period.

The trial investigates early stage Follicular Lymphoma (grades I-IIIA) in patients who have not received prior treatment. It is a prospective, multicenter, open-label, phase III randomized clinical trial comparing two treatment approaches. The study aims to evaluate the progression-free survival over up to 33 months, including a 9-month treatment period followed by 24 months of follow-up. Participants will be randomly assigned to one of two groups. The first group will receive standard involved-site radiation therapy at a dose of 24 Gy. The second group will receive the same radiation therapy followed by obinutuzumab infusions: 4 weekly doses and then 4 additional doses every 3 weeks, totaling 8 doses. This design allows comparison of radiation alone versus radiation combined with obinutuzumab. During the study, participants will have assessments including PET/CT scans for staging, bone marrow biopsies, and blood tests for specific lymphoma markers. Performance status will be monitored, and liver and kidney function will be evaluated. Safety and effectiveness will be tracked throughout treatment and for two years afterward. The main outcome measured is progression-free survival from treatment start through the follow-up period.

Researchers are investigating patients affected by aneurysmal subarachnoid hemorrhage (aSAH), a type of hemorrhagic stroke caused by the rupture of a brain aneurysm, leading to bleeding in the space around the brain. Although early treatment has improved survival, many patients still develop long-term disabling neurological problems. The study focuses on delayed ischemic neurological deficit (DIND), a condition that can lead to delayed cerebral ischemia (DCI) and worsened neurological outcomes. There is no established standard for diagnosing or treating DIND, and the trial aims to describe its incidence, diagnostic imaging findings, and different treatment approaches across centers. The study observes patients with aSAH who require intensive care admission. Early aneurysm repair within 24 to 72 hours is standard, using techniques like endovascular coiling or surgical clipping. The trial collects data on clinical neurological exams and instrumental monitoring such as EEG and ultrasound to identify DIND. Various treatments for DIND are evaluated, including blood pressure management, intra-arterial vasodilator drugs, and mechanical angioplasty. The study also considers innovative methods like stent retriever angioplasty. No specific interventions are assigned by the study; it compares existing diagnostic and therapeutic strategies used in different centers. Participants undergo neurological assessments, brain imaging, and continuous monitoring to detect DIND and evaluate neurological outcomes over time. Researchers collect data on mortality and functional status in the short and long term, as well as treatment intensity and usefulness. The primary measure is the incidence of DIND within 12 months. The total duration of participation depends on patient follow-up. This comprehensive monitoring helps understand how different approaches impact patient recovery and complications after aSAH.

Researchers are evaluating outcomes and their predictors in various neurosurgical conditions using standardized measures agreed upon by multiple centers. The goal is to improve research quality, enable data comparison, and create a common language for routine clinical practice. This approach aims to influence therapeutic decisions and provide more precise guidance to patients undergoing neurosurgery by identifying clinical, cognitive, and psychological factors before and after surgery. The study collects pre- and postoperative clinical, cognitive, and psychological data from patients with a wide range of neurosurgical pathologies including tumors, vascular, traumatic, spinal, functional, peripheral nervous system, and malformative conditions. Data collection includes sociodemographic information, medical history, comorbidities, anesthesiological details, and complications. Enrollment occurs through Neurosurgery Departments, and follow-up timing varies by pathology. Artificial intelligence will be used to analyze associations between preoperative indicators and postoperative outcomes. Participants are followed for up to five years during which comprehensive data are collected. Assessments include clinical evaluations, cognitive and psychological testing, and monitoring of complications and comorbid conditions. The study aims to describe detailed pre- and postoperative status and to identify predictors of outcomes to aid clinical decision-making. Long-term data collection supports understanding of neurosurgical effectiveness and patient quality of life over time.

Researchers are evaluating the effectiveness of niraparib alone versus niraparib combined with bevacizumab as maintenance treatments in women newly diagnosed with advanced stage IIIA/B/C high-grade epithelial ovarian cancer. This phase II, randomized, open-label, multicenter study focuses on patients who have no visible disease remaining after frontline surgery and have completed platinum-based chemotherapy with or without bevacizumab. The study stratifies participants based on BRCA mutation status, cancer stage, and prior hyperthermic intraperitoneal chemotherapy. Participants receive initial chemotherapy with carboplatin and paclitaxel given intravenously every three weeks for five cycles. Bevacizumab (or its biosimilar MVASI) is introduced intravenously starting from the second chemotherapy cycle for five cycles and continued during maintenance therapy for a total of 15 months. After chemotherapy, niraparib is administered orally once daily as maintenance treatment, either alone or in combination with bevacizumab, for up to two years. Throughout the study, participants undergo regular monitoring including imaging scans and laboratory tests to assess disease progression and treatment safety. The main outcome measured is progression-free survival up to 24 months after randomization, defined as the time until tumor progression or death. Researchers also track treatment adherence, side effects, and overall health status during the follow-up period, which lasts up to two years after starting maintenance therapy.

Researchers are conducting a multicenter, prospective observational study to gather clinical data on geriatric patients with hip fractures treated in orthogeriatrics and orthopedics units. The study aims to compare management and clinical methods across centers to promote good clinical practices in orthogeriatrics. The study plans to enroll approximately 7,000 patients aged 65 years and older over a 5-year period, with a 4-month follow-up after enrollment ends. Participating centers can choose between two data collection methods: a high-intensity approach involving continuous data collection for all cases throughout the study, or a low-intensity approach collecting data once a year for one month with fewer variables. This flexibility allows both university-affiliated and non-university assistance departments to participate according to their capacity. Centers decide voluntarily on their preferred data collection intensity after consulting with the study's steering committee and biostatisticians. Participants will be followed for 120 days after enrollment to monitor clinical outcomes and management approaches. The study will continuously collect and compare clinical activity data over approximately 5 years, with the goal of improving care standards. There are no exclusion criteria, and participants or their caregivers must give consent and be able to speak Italian. The study monitors clinical methods and management practices without introducing investigational treatments.