North Kansas City

Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Researchers are investigating the addition of an immunotherapy drug called durvalumab to standard chemotherapy treatment in patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial aims to compare the effectiveness of usual chemotherapy alone versus chemotherapy combined with durvalumab. Immunotherapy with durvalumab may help the immune system attack cancer cells and prevent tumor growth and spread, while chemotherapy drugs like paclitaxel, doxorubicin, and cyclophosphamide work to stop cancer cells from growing or dividing. Previous studies suggest patients with an MP2 result might respond better to this combined treatment approach. Participants first undergo MammaPrint testing to confirm MP2 status before randomization into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide intravenously on day 1 every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously over 60 minutes on specified cycles during both chemotherapy phases. Mammography is performed during screening, and optional tissue and blood samples are collected for future studies. Throughout the study, participants are monitored through various assessments including imaging, physical exams, laboratory tests, and quality of life questionnaires focusing on fatigue and physical and mental health. Researchers track breast cancer event-free survival and other outcomes such as treatment side effects and response rates. After completing treatment, patients are followed for up to 10 years or until death to evaluate long-term outcomes and safety.

Researchers are evaluating the addition of olaparib, a PARP inhibitor, as maintenance therapy following surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have a pathogenic mutation in BRCA1, BRCA2, or PALB2 genes. This phase II randomized, double-blind study aims to determine if olaparib can improve relapse-free survival compared to placebo in these patients, who have completed perioperative chemotherapy and have no evidence of recurrent disease. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, as long as there is no disease progression or unacceptable side effects. Throughout the treatment period, patients undergo imaging tests such as CT scans or MRI and blood sample collections. After completing the treatment cycles, patients are followed up at 30 days, every 4 months for the first year, and then every 6 months for up to 10 years after randomization to monitor their health and disease status. During the study, researchers assess relapse-free survival by documenting any return of cancer or death from 22 to 44 months after randomization. They also collect blood samples and perform imaging tests to monitor the disease and evaluate treatment effects. Safety is carefully monitored, and patients must have recovered from previous treatments before starting the study. The study includes long-term follow-up to observe survival outcomes and any differences based on genetic mutations or prior chemotherapy regimens.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating how well chemotherapy given before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus squamous cell carcinoma that can be removed by surgery. This phase II randomized trial focuses on patients with locally advanced resectable tumors classified as T3 or T4a stages, aiming to preserve important structures like the skull base and orbit, and to improve overall survival. The study also examines additional outcomes such as progression-free survival, the accuracy of imaging predictions, and the effects of tobacco use on treatment and symptoms. Participants are randomly assigned to one of two groups. One group undergoes standard surgery followed by image-guided intensity-modulated radiation therapy (IMRT) daily for 30 treatments starting 4-6 weeks after surgery, with additional chemotherapy (cisplatin or carboplatin) if certain high-risk features are present. The other group receives up to three cycles of chemotherapy including docetaxel and cisplatin (or carboplatin if cisplatin is not suitable), followed by surgery within six weeks. After surgery, they receive the same radiation therapy and additional chemotherapy as needed. The study includes correlative biomarker and questionnaire analyses. Throughout the study, participants have evaluations including magnetic resonance imaging (MRI) and positron emission tomography/computed tomography (PET/CT) scans before registration and during treatment. After completing therapy, patients are followed every three months for up to two years, then every six months up to five years to monitor structure preservation and survival outcomes. Researchers also assess treatment side effects, physical and psychological symptoms, and tobacco use behaviors during this time.

The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

Researchers are evaluating the effectiveness of a combination treatment involving adagrasib, pembrolizumab, and chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. This Phase 2 trial focuses on patients with PD-L1 tumor proportion score (TPS) of 1% or higher, but less than 50%, who have not received prior systemic therapy for advanced disease. The study aims to assess how well this combination works as a first treatment option for this patient group. Participants receive adagrasib as oral tablets twice daily at a dose of 400 mg. Pembrolizumab and chemotherapy drugs (pemetrexed and either cisplatin or carboplatin) are given by intravenous infusion once every three weeks. The study includes several groups based on prior treatments and PD-L1 levels, with some participants having previously completed induction chemotherapy. Treatments are administered according to these schedules and patient eligibility. During the study, researchers monitor participants for tumor response and progression-free survival over 30 months. They use standard criteria to measure tumor size changes and disease progression. Assessments include clinical evaluations and imaging to track response to treatment. Safety and tolerability are also monitored throughout the study period to understand the effects of the combination therapy on patients.

Researchers are evaluating a phase II Lung-MAP treatment trial testing combinations of targeted drugs—capmatinib, osimertinib, and ramucirumab—to treat patients with advanced non-small cell lung cancer (NSCLC) that has spread and shows EGFR and MET gene changes. Capmatinib and osimertinib are kinase inhibitors that block abnormal proteins signaling cancer growth, while ramucirumab is an antibody that may stop new blood vessel growth needed by tumors. Targeting these gene changes may help shrink or control the cancer. Patients are randomized into two groups: one group receives capmatinib and osimertinib orally along with ramucirumab intravenously, while the other group receives capmatinib and osimertinib orally without ramucirumab. Throughout the study, participants undergo CT or MRI scans and provide blood samples. The treatments are given according to the assigned group to compare their effects and safety. During the trial, participants are closely monitored with imaging and blood tests to assess cancer progression and treatment side effects. The main measure is progression-free survival, tracking time until cancer worsens or death, over up to 3 years. Researchers also evaluate response rates, overall survival, toxicity, and collect tissue and blood samples to study tumor DNA. Participants' health status and laboratory values are regularly checked to ensure safety and effectiveness of the treatments.

Researchers are testing a new treatment approach for adults with Stage IIIA or IIIB non-small cell lung cancer. This study compares a shorter, higher-dose radiation schedule called hypofractionated intensity-modulated radiation therapy (IMRT) combined with chemotherapy and followed by an immunotherapy drug called durvalumab, against the standard radiation schedule with the same chemotherapy and immunotherapy. The goal is to see if the new approach improves the control of cancer in the chest area 18 months after treatment. Participants will receive either hypofractionated IMRT with 62.5 Gy delivered in 25 sessions of 2.5 Gy each, or standard IMRT with 60 Gy in 30 sessions of 2 Gy each. Both groups get concurrent chemotherapy with carboplatin and paclitaxel, followed by maintenance treatment with durvalumab. The study is designed as a randomized Phase II trial to evaluate and compare these radiation schedules alongside chemotherapy and immunotherapy. During the trial, participants will be monitored for how well the cancer is controlled locally and regionally for up to 7.5 years after enrollment. Researchers will assess the tumor response using standard criteria and check for any side effects or complications. Regular tests, imaging, and lab work will ensure participants' safety and measure treatment outcomes over the long term.