Farmington

Researchers are evaluating the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab compared to paclitaxel and ramucirumab alone in patients with advanced stomach or esophageal adenocarcinoma. This phase IIIII trial aims to see if nivolumab improves progression-free survival and overall survival in these patients. Nivolumab is an immunotherapy monoclonal antibody that may help the immune system attack cancer, while ramucirumab may prevent tumor blood vessel growth, and paclitaxel stops cancer cells from dividing. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, combined with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives only ramucirumab and paclitaxel on the same schedule without nivolumab. Treatment cycles continue unless the disease worsens or side effects become unacceptable. During the study, patients undergo CT scans and MRI imaging, and may optionally provide blood samples. Throughout the trial, participants are monitored with regular imaging and optional blood tests. After treatment ends, patients have follow-up visits at 30, 60, and 90 days, then every six months for up to three years. Researchers assess progression-free survival, overall survival, response rates, disease control, safety, and quality of life using questionnaires and patient-reported symptoms. This comprehensive monitoring helps evaluate treatment effects and patient well-being over time.

Researchers are evaluating a new approach to adjuvant treatment for patients with early-stage endometrial cancer characterized by POLE mutations or p53 wildtypeno specific molecular profile. This Phase II study compares this tailored treatment approach to the usual care, which typically involves surgery followed by additional therapy decisions based on pathology results. The study includes two sub-studies focusing on these molecular types of endometrial cancer. Participants may receive one of several interventions including observation alone, observation combined with adjuvant radiotherapy, or observation combined with vaginal brachytherapy. Radiotherapy uses specific photon energies and imaging for treatment planning, while vaginal brachytherapy is delivered with a vaginal cylinder or ovoids. Treatment starts within 10 weeks after surgery, and patients are assigned to groups based on their tumor molecular status. During the study, participants are monitored for recurrence rates in the pelvis, vagina, para-aortic area, and distant sites over 3 years, as well as recurrence-free survival, cancer-specific survival, and overall survival over 9 years. Patient-reported outcomes on fear of recurrence are also collected. Careful follow-up and data collection continue throughout the study, which concludes in 2029, ensuring thorough evaluation of this tailored treatment approach.

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 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 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 evaluating whether high-dose gabapentin can reduce the need for opioid pain medications in patients experiencing mouth sores oral mucositis caused by chemotherapy and radiation treatment for squamous cell carcinoma of the head and neck. Oral mucositis can cause severe pain and complications such as difficulty swallowing, weight loss, feeding tube placement, interruptions in cancer treatment, hospitalizations, and decreased quality of life. Opioids are commonly used to treat this pain but come with significant side effects and risks of long-term use. In this phase III trial, patients are randomly assigned to receive either gabapentin or a placebo starting at radiation treatment day 8. The medication is given orally once daily on day 1, twice daily on day 2, and three times daily from day 3 onward. Both groups also receive standard chemotherapy, radiation, and pain management. Treatment continues until symptoms improve and other pain medications are stopped, followed by a gradual reduction in the study drug dose. Blood samples are collected throughout the study. After treatment, patients are followed for up to 6 months. Participants will have their need for opioids monitored during chemoradiation, along with the time to first opioid use and pain scores assessed up to 4 weeks after treatment ends. Researchers will also explore opioid use duration, symptom and quality of life changes, adverse events, medication tolerance, body weight, kidney function, immune cell counts, and feeding tube requirements. Study visits include regular assessments, blood tests, and questionnaires to gather detailed information on patient outcomes and safety.

Researchers are evaluating treatments for patients with high-risk, locally advanced cervical cancer that has spread to nearby tissue or lymph nodes. This Phase III trial compares adding induction chemotherapy with carboplatin, paclitaxel, and pembrolizumab before standard chemotherapy, radiation, and pembrolizumab maintenance against the standard treatment of chemotherapy, radiation, and pembrolizumab maintenance alone. The study aims to investigate whether this induction approach improves progression-free survival and overall survival, while assessing treatment toxicity and biomarker effects. Participants are randomly assigned to one of two groups. In the standard care group, patients receive weekly cisplatin and pembrolizumab every three weeks alongside daily radiation therapy for 5 weeks, followed by brachytherapy for 4 to 5 treatments, and then pembrolizumab maintenance every six weeks for up to 15 cycles. In the experimental group, patients first receive induction chemotherapy with carboplatin and paclitaxel weekly for 3 weeks, plus pembrolizumab every three weeks for 2 cycles, then receive the same chemoradiation and pembrolizumab maintenance schedule, with radiation delivered in weeks 7 to 13. Treatment is given unless disease progression or unacceptable side effects occur. Throughout the trial, participants undergo imaging scans including PET, CT, chest x-ray, and MRI, along with blood sample collection to monitor disease and biomarkers. After completing treatment, patients are followed every 3 months for 2 years, then every 6 months for up to 3 more years. Researchers measure progression-free survival as the primary outcome and assess overall survival, adverse events, treatment completion, biomarker levels, and radiation quality. Safety and treatment effects are closely monitored during the study period lasting several years.

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 evaluating whether simply observing patients after surgery is as effective as continuing pembrolizumab treatment in preventing cancer recurrence in people with early-stage triple-negative breast cancer TNBC who had a complete response after receiving chemotherapy plus pembrolizumab before surgery. This Phase III trial aims to determine if stopping pembrolizumab post-surgery can maintain recurrence-free survival while potentially improving quality of life and reducing treatment burden. Participants are randomly assigned to one of two groups after finishing chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab intravenously every 3 or 6 weeks for 27 weeks. The other group undergoes observation without further pembrolizumab for the same period. Throughout the study, patients have tumor biopsies and blood collected, along with imaging such as mammography, breast ultrasound, or MRI during follow-up. Participants will be monitored for recurrence-free survival and overall survival for up to 10 years. The study also assesses adverse events, quality of life, financial impact, and work productivity at about 27 weeks after starting the assigned treatment or observation. Safety and treatment effects are tracked through biopsies, imaging, blood tests, and patient questionnaires during the study and follow-up.

Researchers are evaluating new treatments for acute hypoxemic respiratory failure AHRF, a serious condition that affects millions worldwide each year and carries high risks of death and long-term health problems. This platform trial, called PRACTICAL, uses adaptive methods to test various interventions at different stages, including mechanical ventilation approaches, extracorporeal life support, drugs, and medical devices. The study aims to find better strategies to protect lungs and diaphragm function during ventilation and improve patient outcomes. The trial includes multiple domains studying different treatments or strategies. These include ultra-protective ventilation using extracorporeal carbon dioxide removal, various invasive mechanical ventilation strategies, corticosteroid use in early and extended phases, nebulized furosemide, positive end-expiratory pressure settings during extracorporeal support, fludrocortisone for airspace disease, and inspiratory muscle training. Some domains are observational, collecting data and biomarkers in immunocompromised patients or examining patient-ventilator interactions. Participants will be randomized to different treatment arms or observed, depending on the domain. Participants will undergo assessments including physiological and biological measurements, mechanical ventilation monitoring, and evaluation of clinical outcomes such as mortality, ventilator-free days, organ failure, and long-term cognitive and physical function. Data will be collected daily or at specified time points up to 180 days. The study uses Bayesian adaptive analysis to efficiently evaluate efficacy and safety of interventions. The total participation time varies by domain but includes active treatment periods, follow-up, and feasibility assessments over months to years.