Delaware County

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are evaluating whether brain MRI scans alone can effectively monitor small cell lung cancer compared to the combination of MRI scans with preventive brain radiation called prophylactic cranial irradiation (PCI). This phase III trial aims to see if using MRI surveillance alone can maintain overall survival and reduce side effects, potentially prolonging patients' lives. The study also looks at cognitive function, brain metastasis-free survival, and treatment toxicities. Participants are randomly assigned to one of two groups. One group receives PCI radiation therapy to the brain over two weeks along with scheduled MRI scans at 3, 6, 9, 12, 18, and 24 months. The other group only undergoes MRI scans at the same time points without PCI. Some patients in the PCI group may receive hippocampal avoidance radiation to spare cognitive function. During the study, participants undergo regular MRI scans and cognitive testing to track brain health and cancer spread. Researchers monitor survival rates, cognitive failure-free survival, brain metastases occurrence, and adverse events for up to two years after randomization. Blood samples may be collected for banking. The total follow-up includes multiple visits and assessments to evaluate the effects of MRI surveillance alone versus combined PCI and MRI monitoring.

Researchers are evaluating the addition of pembrolizumab, an immunotherapy drug, to usual chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival between different treatment approaches, including chemotherapy alone and chemotherapy combined with pembrolizumab. The study also assesses quality of life, side effects, and the impact of tumor markers on outcomes. Patients are randomly assigned to one of two active treatment groups. One group receives standard chemotherapy every 21 days for 4 cycles followed by pembrolizumab given intravenously every 21 days or every 6 weeks for up to 17 cycles. The other group receives chemotherapy combined with pembrolizumab during the initial 4 cycles, followed by pembrolizumab alone for additional cycles. Chemotherapy regimens include combinations of cisplatin, carboplatin, pemetrexed, gemcitabine, or paclitaxel. A previous group receiving chemotherapy alone followed by observation is closed. Participants undergo various assessments including echocardiograms, MRIs, CT scans, and blood sample collections during the trial. They complete quality of life questionnaires and are monitored regularly for disease recurrence, side effects, and survival for up to 10 years. Follow-up visits occur every 3 months for 2 years, then every 6 months for years 2 to 4, and annually thereafter, providing long-term monitoring of treatment effects and safety.

Researchers are evaluating whether adding radiation therapy to the usual maintenance treatment with atezolizumab helps patients with extensive stage small cell lung cancer that has spread beyond the lungs. The trial compares this combination versus atezolizumab alone following prior treatment with atezolizumab plus chemotherapy. The study aims to see if radiation can extend the time before the cancer grows or spreads further and improve overall survival while monitoring side effects and tumor characteristics. Participants are randomly assigned to one of two groups. One group receives atezolizumab intravenously every 21 days without radiation. The other group receives the same atezolizumab schedule plus radiation therapy once daily on days 1-5 for five weeks. Both groups undergo scans including PET/CT, CT, and MRI throughout the trial and have blood and tissue samples collected. After treatment, follow-up visits occur every 3 months for 2 years, then every 6 months for 3 years, and annually afterward. During the study, participants undergo multiple imaging tests and laboratory assessments to monitor cancer progression and treatment effects. Researchers measure progression-free survival and overall survival as primary outcomes, along with side effects and responses in patients with different tumor burdens. The study continues to track participants for up to six years to assess long-term outcomes and safety.

Researchers are evaluating whether adding the drug apalutamide to the usual hormone therapy and radiation therapy after surgery improves outcomes for men with prostate cancer that has spread to lymph nodes. This phase III trial focuses on patients who have undergone radical prostatectomy and have detectable prostate-specific antigen (PSA), aiming to see if apalutamide can help prevent the cancer from spreading further and extend the time without metastasis. Participants are randomly assigned to one of two groups. One group receives standard hormone therapy and radiation to the pelvis and prostate bed for 5 to 8 weeks. The other group receives the same treatment plus daily oral apalutamide for 90 days per cycle, repeated for up to eight cycles, unless disease progression or unacceptable side effects occur. Both groups may undergo imaging tests like CT, MRI, bone scans, and PET scans as needed, along with blood sample collections. Throughout the study, participants are closely monitored with scans and blood tests to assess cancer progression and treatment effects. Researchers will measure metastasis-free survival as the primary outcome, along with quality of life, overall survival, biochemical progression, time to local progression, castrate resistance, cancer-specific survival, and adverse events. After treatment, participants will have follow-up visits every six months for three years, then yearly thereafter to track long-term outcomes.

Researchers are investigating treatments for men with prostate cancer that has returned after surgery, specifically those with biochemical recurrence indicated by rising prostate specific antigen (PSA) levels. This phase III trial examines whether adding enhanced therapy, which includes apalutamide combined with abiraterone and prednisone, to standard care (prostate radiation therapy and short-term androgen deprivation) improves outcomes compared to standard care alone. The study also explores if adding targeted radiation to metastatic sites identified by PET imaging benefits patients whose cancer has spread beyond the pelvis. Participants undergo a baseline PET scan using CT or MR imaging to detect cancer spread. Based on these results, they are randomized into one of four treatment groups: standard radiation plus androgen deprivation; standard radiation, androgen deprivation, and apalutamide; similar treatments for those with metastases; and a group receiving additional targeted radiation to metastatic sites. Treatments last approximately six months, with radiation delivered through various advanced techniques, and hormonal therapies given via injections or orally. Some patients may have repeat PET scans during the study to monitor disease progression. During the trial, participants will have regular follow-up visits every three months for two years, then less frequently up to ten years. Researchers will assess progression-free survival, overall survival, PSA levels, quality of life, cognitive function, and adverse events. Quality of life and fatigue questionnaires are administered at several time points. Safety and treatment responses will be closely monitored using imaging and lab tests throughout the study duration.