Buena Park

Researchers are studying two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 genetic mutations. This trial compares bilateral salpingectomy, which removes only the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The goal is to find out if removing just the fallopian tubes with delayed ovary removal is nearly as effective as removing both from the start. Participants choose between two groups one undergoes bilateral salpingectomy with the option of later ovary removal, and the other undergoes bilateral salpingo-oophorectomy. Both groups have imaging tests like pelvic ultrasounds or pelvic MRIs during screening and provide blood samples throughout the study. Follow-up visits occur at multiple time points, including 10 to 60 days, 6 months, 12 months, 24 months, and then yearly for up to 20 years. During the study, researchers track if ovarian or related cancers develop and assess symptoms related to estrogen loss, quality of life, cancer-related distress, sexual function, menopausal symptoms, medical decision making, and any adverse events. Various questionnaires and imaging tests support these evaluations. Long-term safety and cancer risk reduction are monitored for up to two decades after surgery.

Researchers are investigating treatments for patients with metastatic kidney cancer, focusing on whether adding surgery to a standard immunotherapy-based drug combination improves overall survival. This phase III trial compares outcomes for patients receiving immunotherapy with or without surgery to remove the kidney, known as nephrectomy. Immunotherapy drugs like nivolumab, ipilimumab, pembrolizumab, and avelumab aim to help the immune system attack the cancer, while axitinib works to block tumor growth. The benefit of adding surgery to these drug treatments is not yet established. Participants first receive one of three standard immunotherapy-based regimens before randomization, including combinations of intravenous nivolumab, ipilimumab, pembrolizumab, avelumab, and oral axitinib. After about 10 to 14 weeks of this initial treatment, patients are randomly assigned to continue systemic therapy alone or to receive surgery to remove the kidney plus the same systemic therapy. Surgery may be radical or partial and performed using laparoscopic, open, or robotic methods within 8 weeks of randomization. Axitinib is paused before surgery and resumed after recovery. Throughout the study, participants undergo scans and clinical assessments to monitor tumor response and side effects. After completing treatment, patients are followed up every 3 months during the first year, then every 6 months for years two and three, and annually thereafter for up to seven years. The trial measures overall survival, tumor response in metastatic sites, changes in tumor size, and complications from surgery or drug toxicities. Specimens are also collected for future research to better understand the disease and treatments.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating whether adding the drug TRC102 to the usual chemotherapy and radiation treatment followed by durvalumab can better shrink tumors in patients with stage III non-squamous non-small cell lung cancer NSCLC. This phase II trial explores whether the combination therapy improves progression-free survival compared to the standard treatment alone. TRC102 blocks cancer cells ability to repair DNA damage, potentially helping other anticancer drugs work more effectively. Participants are randomly assigned to one of two treatment groups. One group receives TRC102 orally along with pemetrexed and either cisplatin or carboplatin intravenously, plus daily radiation therapy Monday through Friday for two 21-day cycles, followed by durvalumab infusions every 2 weeks or monthly for up to one year. The other group receives the usual chemotherapy and radiation followed by durvalumab on the same schedule. Imaging scans such as CT, MRI, and FDG-PETCT are done at screening and throughout the trial to monitor the cancer. During the study, participants will be closely monitored with regular imaging scans and clinical assessments. After completing treatment, follow-up visits occur at 30 days, then every 3 months for 2 years, and every 6 months for an additional 3 years to track progression-free survival, overall survival, and any side effects. The total participation time can extend up to 5 years to fully evaluate the outcomes and safety of the treatments.

Researchers are evaluating the addition of BMX-001 to usual symptom management compared to usual symptom management alone to reduce oral mucositis in patients receiving chemoradiation for head and neck cancer. Oral mucositis, which causes inflammation and mouth sores, is a common side effect of chemoradiation that can lead to pain and difficulty swallowing. This phase II trial aims to compare the incidence and duration of severe oral mucositis, as well as other side effects like xerostomia and radiation dermatitis, between the two treatment groups. Participants are randomly assigned to one of two groups. Both receive cisplatin chemotherapy once weekly or every three weeks and undergo image-guided intensity-modulated radiation therapy daily for seven weeks. In addition to usual symptom management, one group receives placebo injections subcutaneously twice a week for eight weeks, while the other group receives BMX-001 injections on the same schedule. Imaging such as CT and MRI scans and optional blood, serum, or plasma collection occur during the study. Throughout the trial, participants complete questionnaires and are monitored for side effects, toxicities, and oral mucositis severity up to 24 months after completing treatment. Follow-up visits occur at 1, 2, 3, 6, 12, and 24 months. Researchers assess patient-reported symptoms, duration of oral mucositis, radiation dermatitis, and overall survival outcomes. The trial also collects biological samples for future research.

Researchers are evaluating the effect of chemotherapy drugs capecitabine and temozolomide after surgery in patients with high-risk well-differentiated pancreatic neuroendocrine tumors. This phase II trial compares treatment with these drugs to observation only, aiming to see if chemotherapy can prevent or delay cancer recurrence and improve survival. The study also assesses the safety and tolerability of this chemotherapy combination and collects specimens for future research. Participants are randomly assigned to one of two groups. In the first group, patients take capecitabine twice daily on days 1 to 14 and temozolomide once daily on days 10 to 14, repeating this 28-day cycle for up to 4 cycles if there is no disease progression or unacceptable side effects. The second group undergoes surveillance without active treatment. After treatment or observation, all patients are followed every 6 months for 3 years, then annually until 5 years from randomization. During the study, participants will have regular medical exams and scans to monitor for cancer recurrence or progression. Researchers will assess recurrence-free survival as the primary outcome over up to 5 years, with overall survival and side effects also tracked. Safety evaluations are done up to 30 days after treatment completion. This long-term follow-up helps understand how well patients do after surgery with or without chemotherapy.