Collierville

Researchers are evaluating the effect of adding intensity-modulated post-operative radiation therapy I-PORT to standard chemotherapy or immunotherapy in patients with non-small cell lung cancer NSCLC who still have lymph node cancer after surgery. This phase II trial aims to see if I-PORT improves disease-free survival and whether it increases serious heart or lung side effects compared to standard care alone. The study also looks at overall survival, cancer control, and patient-reported symptoms related to heart and lung health. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy or immunotherapy alone, continuing treatment if the cancer does not progress or side effects are manageable. The other group receives I-PORT once daily Monday through Friday for 5 to 6 weeks, starting 4 to 12 weeks after surgery, followed by the same standard chemotherapy or immunotherapy. Imaging scans and blood samples are collected during treatment in both groups. After completing treatment, participants are followed for five years with check-ups every three months for two years, then every six months for three years. During these visits, researchers assess disease recurrence, survival, side effects, and patient symptoms. The study uses various scans including CT, MRI, and FDG-PET, along with blood tests, to monitor participants health and treatment impact over time.

This trial studies the safety and tolerability of different doses of PCRX-201, an investigational injection, for adults aged 45 to 80 with painful osteoarthritis of the knee. It compares two doses of PCRX-201 to placebo over one year, assessing adverse events and exploring effects on knee pain and joint function. The study includes two parts using PCRX-201 manufactured by different processes, enrolling 135 participants with specific knee osteoarthritis grades. Participants receive a single knee injection of PCRX-201 or placebo after a steroid pretreatment with methylprednisolone acetate. The study randomly assigns subjects to dose groups stratified by knee osteoarthritis severity using X-rays and MRI or ultrasound for synovitis assessment. Part A enrolls 45 subjects Part B enrolls 90 subjects, contingent on drug availability. Both parts include careful screening and dosing procedures. Participants attend multiple clinic visits for pretreatment, injection, and follow-up assessments. Visits occur weekly, bi-weekly, and then monthly through Week 52, followed by 8 visits over the next four years. Researchers monitor adverse events, inflammation markers, antibody levels, and knee pain through questionnaires and laboratory tests. The total participation can last up to five years for long-term safety and effectiveness monitoring.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

Researchers are evaluating the addition of a live biotherapy called MO-03 to standard immunotherapy treatments in patients with advanced or metastatic clear cell renal cell carcinoma, a type of kidney cancer that has spread beyond its original site. This phase III trial compares the effects of standard immunotherapy alone versus standard immunotherapy combined with MO-03, which contains beneficial bacteria that may improve gut health and potentially enhance immunotherapy effectiveness. Participants are randomly assigned to one of two groups one group receives MO-03 orally twice daily along with standard immunotherapy regimens tailored by risk level, and the other group receives a placebo along with the same immunotherapy regimens. The immunotherapy regimens include various drugs such as ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, administered intravenously or orally over cycles lasting 42 days, for up to 3 years unless disease progression or unacceptable side effects occur. Throughout the study, participants undergo regular imaging scans like CT or MRI and blood tests to monitor their health and response to treatment. Those with suspected bone or brain metastases may have additional scans. After completing treatment, participants are followed every 6 months for 2 years, then annually for up to 5 years to assess progression-free survival, overall survival, treatment response, and safety. Biological samples are also collected for future research.

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase IIIII trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.

Differentiating septic arthritis from other causes of joint inflammation in children is critical because septic arthritis requires prompt surgical treatment to prevent lasting joint damage. This study aims to evaluate the accuracy of several synovial fluid biomarkers, including alpha-defensin and others, in diagnosing pediatric septic arthritis. The research focuses on improving rapid diagnosis since current culture methods take several days, causing delays in treatment decisions. Participants include children under 18 years old undergoing joint fluid sampling due to suspected infection or inflammation, as well as normative controls undergoing unrelated procedures without infection. Various synovial fluid tests will be performed, such as alpha-defensin assay, leukocyte esterase test, neutrophil elastase, synovial C-reactive protein, and culture tests. Blood tests and PCR for Kingella kingae in children under 8 will also be conducted. These tests will be compared to joint fluid culture, the current gold standard. Participants take part in one study visit during which joint aspiration or arthroscopy is performed as part of their usual care. Researchers will analyze the synovial fluid and blood samples for these biomarkers and compare results to culture outcomes. The primary outcome is the sensitivity and specificity of these experimental tests for diagnosing infection. Data from this single visit will help determine if these tests can improve early detection of pediatric septic arthritis.

Researchers are studying the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

Researchers are evaluating combinations of targeted drugs in people with advanced non-small cell lung cancer that has spread and shows specific changes in the EGFR and MET genes. This phase II Lung-MAP trial focuses on patients whose cancer has progressed after treatment with osimertinib and aims to compare the effectiveness of combining capmatinib, osimertinib, and ramucirumab. The study also investigates safety, response rates, and survival outcomes while collecting biological samples for further analysis. Participants are randomly assigned to one of two groups. One group receives capmatinib and osimertinib as oral medications plus ramucirumab given intravenously, while the other group receives only capmatinib and osimertinib orally. During the trial, patients undergo regular CT or MRI scans and blood sample collections to monitor their disease and treatment effects. The study includes detailed assessments of tumor responses and side effects over time. Throughout the trial, participants will have scans and blood tests at scheduled intervals to assess disease progression and treatment impact. Researchers will monitor progression-free survival as the main outcome, along with response duration and toxicity. Blood samples are also collected to study circulating tumor DNA. The study continues up to three years, with ongoing safety and efficacy evaluations. Participants must meet specific health criteria and provide informed consent before joining.