Monroe

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 evaluating the effects of lenalidomide and dexamethasone with or without daratumumab in treating patients with high-risk smoldering multiple myeloma. This phase III trial aims to compare overall survival, progression-free survival, response rates, and safety between these treatments. The study also explores patient-reported quality of life, treatment adherence, minimal residual disease status, and imaging associations during therapy. Participants are randomly assigned to one of two treatment groups. The first group receives daratumumab intravenously on a detailed schedule across up to 24 courses, plus oral lenalidomide daily for 21 days and dexamethasone on specific days during the first 12 courses. The second group receives only oral lenalidomide and dexamethasone on a similar schedule for up to 24 courses. Treatment cycles repeat every 28 days unless disease progression or unacceptable side effects occur. During the study, participants complete quality-of-life questionnaires and undergo laboratory tests, including minimal residual disease assessments and PETCT imaging. Safety is closely monitored, especially infusion-related reactions and toxicity. After treatment, patients are followed for up to 15 years with periodic visits every 3 to 12 months to track long-term outcomes and survival.

Researchers are evaluating letrozole treatment in women newly diagnosed with uterine leiomyosarcoma, a type of cancer limited to the uterus. This randomized phase II study compares daily letrozole to observation to see if letrozole can extend the time patients remain free from disease progression. The main goal is to measure progression-free survival up to three years from randomization. Participants will be randomly assigned to receive either 2.5 mg of letrozole orally once daily or no treatment observation. The study includes patients with early-stage disease FIGO 2009 Stage I who have completed surgery with hysterectomy and bilateral salpingo-oophorectomy within 12 weeks before enrollment. The study uses adaptive randomization to assign patients to either group. During the trial, participants will be monitored regularly to detect any disease progression or death. The main measurement is the time from enrollment until progression or death. Participants must meet specific health criteria, including no measurable disease at enrollment and adequate organ function. The study will continue until July 2029, with primary outcome data collected up to three years after randomization.

Researchers are comparing two chemotherapy combinations for treating advanced, unresectable, or metastatic HER2 negative adenocarcinomas of the esophagus, gastroesophageal junction, and stomach. This phase III trial evaluates modified FOLFIRINOX fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan with or without nivolumab versus modified FOLFOX fluorouracil, leucovorin calcium, and oxaliplatin with or without nivolumab. Chemotherapy drugs act to stop tumor growth by killing cells or stopping division, and immunotherapy with nivolumab may affect the immune system to hinder tumor growth and spread. Participants are randomized into two groups one receives mFOLFIRINOX plus nivolumab as clinically indicated, and the other receives mFOLFOX plus nivolumab as clinically indicated. Treatments are administered intravenously. Throughout the study, participants undergo magnetic resonance imaging MRI, computed tomography CT scans, and may provide blood samples. Nivolumab is given as needed based on clinical assessment during the trial. Participants will be monitored up to 2 years from randomization for overall survival, with secondary measures including progression-free survival, response rates, duration of response, adverse events, and patient-reported outcomes collected at baseline and during treatment cycles. Safety and tolerability are evaluated, and exploratory analyses include biomarker assessments such as PD-L1 combined positive score and cell-free DNA. The trial includes regular imaging and clinical assessments to track disease status and treatment effects.

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.

This trial studies adults with advanced non-small cell lung cancer NSCLC that has spread outside the lungs and has specific mutations in the EGFR gene. Researchers are comparing two treatment approaches osimertinib alone versus osimertinib combined with bevacizumab. The study aims to evaluate how these treatments affect the time patients live without disease progression and overall survival, as well as their effects on brain metastases and treatment safety. Participants are randomly assigned to one of two groups. One group receives osimertinib pills daily every 21 days, while the other group receives osimertinib daily plus an intravenous infusion of bevacizumab every 21 days. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants undergo tests including echocardiography, MUGA scans, CT scans, and possibly MRI, along with blood and urine sample collection. After treatment ends, participants are followed every three months for up to 10 years to monitor disease status and survival. Researchers will assess progression-free survival, overall survival, response rates, time to brain progression, and side effects. The study includes long-term follow-up to understand the lasting effects of these treatments and to explore resistance mechanisms through tumor DNA analysis.

Researchers are evaluating the effectiveness of ramucirumab combined with paclitaxel versus the FOLFIRI regimen leucovorin calcium, fluorouracil, and irinotecan hydrochloride in treating patients with advanced or treatment-resistant small bowel adenocarcinoma. Ramucirumab is a monoclonal antibody that targets VEGFR-2 to potentially reduce tumor blood supply and growth. Chemotherapy drugs like paclitaxel, leucovorin calcium, fluorouracil, and irinotecan work by stopping tumor cell growth through different mechanisms. Participants are randomly assigned to one of two treatment groups. In the first group, patients receive ramucirumab intravenously over 30-60 minutes on days 1 and 15, and paclitaxel intravenously over 30 minutes on days 1, 8, and 15, with each cycle lasting 28 days. In the second group, patients receive irinotecan intravenously over 90 minutes on days 1 and 15, leucovorin intravenously over 2 hours on days 1 and 15, and fluorouracil both as an IV bolus on days 1 and 15 and continuously over 46-48 hours on days 1-3 and 15-17. Treatment cycles repeat every 28 days unless disease progresses or side effects become unacceptable. During the study, patients are monitored with assessments every 8 weeks until their disease progresses. After progression, follow-up continues every 6 months for up to 3 years. Researchers measure progression-free survival, overall response rate, overall survival, and track any adverse events. Tissue and blood samples are also collected for future research. Patient safety and treatment effects are carefully evaluated throughout the study.

Researchers are evaluating how well serum tumor marker directed disease monitoring STMDDM works compared to usual care in patients with hormone receptor positive, HER2-negative metastatic breast cancer. This trial aims to see if monitoring with serum tumor markers can provide similar overall survival outcomes to the standard approach, which involves regular imaging scans. The study also looks at healthcare costs, patient anxiety, and quality of life related to these monitoring methods. Participants are randomly assigned to one of two groups. In the usual care group, patients receive imaging studies at least every 12 weeks and may have serum tumor marker tests as determined by their doctor. In the STMDDM group, patients have blood tests for specific tumor markers every 4 to 8 weeks, and imaging scans are only done if these markers indicate a possible progression of disease. Both groups continue their monitoring for up to 312 weeks unless the disease progresses. During the study, participants undergo regular assessments including blood tests for tumor markers, imaging scans as needed, and questionnaires about anxiety and quality of life. Researchers track overall survival for up to 312 weeks and compare healthcare costs and patient-reported outcomes for up to 48 to 102 weeks. The study also collects data on how often and by what methods disease monitoring is performed, along with patient and physician preferences related to monitoring.

Researchers are evaluating a phase III trial comparing shorter chemotherapy-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer TNBC. This study aims to see if the shorter treatment works as well as the usual anthracycline-containing treatment. The trial also assesses patient-reported outcomes like fatigue and physical function, as well as safety and survival measures. It involves participants with specific stages of TNBC and includes detailed evaluations of tumor response and immune markers. Participants are randomly assigned to one of two treatment groups. One group receives paclitaxel, carboplatin, and pembrolizumab followed by doxorubicin, cyclophosphamide, and pembrolizumab, then surgery, with possible pembrolizumab after surgery. The other group receives docetaxel, carboplatin, and pembrolizumab prior to surgery, with possible pembrolizumab after surgery. Blood samples may be collected throughout the trial for research purposes. During the study, participants undergo surgery after chemotherapy-immunotherapy. They are followed every six months for two years, then annually up to five years. Assessments include breast cancer event-free survival, pathological response, distant relapse-free survival, overall survival, adverse events, and patient-reported fatigue and physical function. Quality of life and other patient-reported symptoms are also evaluated. Specimens are banked for future research. The total participation may last up to five years from registration.

This research aims to develop a stepped-care talk therapy model for patients with PTSD, focusing on whether starting with one type of therapy is better than another, and if switching therapies after four sessions based on early response helps more than continuing the same therapy. The study tests the hypothesis that beginning with low- or medium-intensity PTSD interventions and adjusting treatment intensity based on early results will effectively reduce PTSD symptoms while using resources efficiently. Participants receive different behavioral therapies including Prolonged Exposure for Primary Care PE-PC, Full Prolonged Exposure, or a Clinician Supported PTSD Coach App. Treatments begin with four weekly sessions or nine weeks of clinician support, followed by adjustments depending on early response. Early responders may reduce session frequency, while slow responders may switch to more intensive therapy or continue current therapy with altered session schedules. During the study, participants undergo regular clinical assessments including PTSD symptom evaluations using the Clinician-Administered PTSD Scale CAPS-5 and self-reported measures like the PTSD Checklist PCL-5, Patient Health Questionnaire PHQ-9 for depression, and quality of life surveys at baseline and three months. The study monitors symptom changes and treatment adjustments over time, with participation lasting through the treatment and follow-up periods to assess outcomes and resource use.