Balashikha

Researchers are evaluating whether adding repeated cisplatin-based pressurized intraperitoneal aerosol chemotherapy PIPAC to standard taxane and platinum TC chemotherapy improves outcomes in women aged 18 to 75 years with advanced epithelial ovarian cancer and visible peritoneal carcinomatosis FIGO stages IIIB-IIIC. The study aims to determine if repeated PIPAC increases the rate of complete surgical tumor removal and improves disease control, survival, and safety compared to standard treatment that includes only one PIPAC procedure. This phase II randomized trial also explores the best way to combine PIPAC with systemic chemotherapy and surgery for this condition. Participants are randomly assigned to one of two groups one group receives multiple PIPAC procedures integrated with systemic TC chemotherapy and interval cytoreductive surgery, while the other group receives systemic chemotherapy, surgery, and only a single PIPAC treatment during surgery. In cases where complete tumor removal is not achieved, a crossover treatment includes additional PIPAC after surgery with further chemotherapy. PIPAC is delivered laparoscopically under general anesthesia using cisplatin aerosolized into the abdominal cavity under controlled pressure and flow. Throughout the study, participants undergo diagnostic laparoscopy, biopsies, repeated clinical and laboratory assessments, imaging, tumor marker tests, and monitoring for side effects. The main outcome is the rate of complete surgical tumor removal assessed about 9 to 12 weeks after randomization. Secondary outcomes include survival, disease progression, tumor marker response, ascites control, adverse events, and wound healing. Follow-up continues for up to two years with assessments of cancer control and quality of life. Safety measures are in place to protect patients and staff during PIPAC procedures.

Researchers are evaluating the effectiveness of adjuvant ribociclib combined with hormone therapy using aromatase inhibitors with or without GnRH agonists in patients with hormone receptor-positive HR HER2-negative stage II-III breast cancer. This observational study includes two groups a prospective cohort receiving ribociclib plus aromatase inhibitors, and a retrospective cohort treated with aromatase inhibitor monotherapy. The study aims to analyze outcomes based on tumor grade, lymph node involvement, and hormone therapy response in real-world clinical practice in Russia. Participants in the prospective group receive ribociclib along with aromatase inhibitors GnRH agonists, while the retrospective group includes patients treated with aromatase inhibitor monotherapy. Data collection includes both primary prospective data and secondary retrospective data from medical records. The study does not involve experimental treatment assignments but observes existing treatment patterns and outcomes. Participants will be monitored over several years with assessments at months 36, 48, and 60 to evaluate invasive breast cancer-free survival and other related outcomes. Quality of life questionnaires and safety data including adverse events are collected at multiple time points up to 60 months. The study involves continuous data review to assess treatment adherence, disease recurrence, and patient well-being throughout the observation period.