Bel Air

Researchers are evaluating whether adding radiation before chemoimmunotherapy and surgery is effective for people with non-small cell lung cancer (NSCLC) who may be eligible for surgery. This Phase 1 study focuses on patients with borderline resectable NSCLC and aims to assess the tolerability of combining stereotactic body radiation therapy (SBRT) with standard chemoimmunotherapy. The standard chemoimmunotherapy includes chemotherapy drugs such as carboplatin or cisplatin with pemetrexed, paclitaxel, or gemcitabine, along with the immunotherapy drug nivolumab. Participants will receive three doses of SBRT radiation every other day over three days, with the final radiation dose given within seven days of starting chemoimmunotherapy. The chemoimmunotherapy regimen involves intravenous nivolumab every three weeks for up to three cycles (totaling nine weeks), combined with chemotherapy drugs as described. After completing these treatments, patients will be evaluated for surgical removal of the tumor. During the study, participants will be followed for up to 100 days after their last chemoimmunotherapy dose to monitor side effects. Researchers will review medical records during and after this period to track cancer outcomes such as survival and recurrence. The study measures tolerability of adding radiation to the standard treatment within 20 weeks of starting therapy, aiming to better understand the combined treatment's safety and effects.

Researchers are investigating the addition of an immunotherapy drug called durvalumab to standard chemotherapy treatment in patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial aims to compare the effectiveness of usual chemotherapy alone versus chemotherapy combined with durvalumab. Immunotherapy with durvalumab may help the immune system attack cancer cells and prevent tumor growth and spread, while chemotherapy drugs like paclitaxel, doxorubicin, and cyclophosphamide work to stop cancer cells from growing or dividing. Previous studies suggest patients with an MP2 result might respond better to this combined treatment approach. Participants first undergo MammaPrint testing to confirm MP2 status before randomization into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide intravenously on day 1 every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously over 60 minutes on specified cycles during both chemotherapy phases. Mammography is performed during screening, and optional tissue and blood samples are collected for future studies. Throughout the study, participants are monitored through various assessments including imaging, physical exams, laboratory tests, and quality of life questionnaires focusing on fatigue and physical and mental health. Researchers track breast cancer event-free survival and other outcomes such as treatment side effects and response rates. After completing treatment, patients are followed for up to 10 years or until death to evaluate long-term outcomes and safety.

Researchers are evaluating the antidepressant effects of ALTO-100 compared to a placebo in adults with Bipolar Disorder I or II who are currently experiencing a major depressive episode. This Phase 2 study focuses on patients who are also taking mood stabilizers and/or atypical antipsychotic medications. The study aims to understand differences in efficacy related to patient characteristics, while also assessing safety and tolerability. Participants will receive either ALTO-100 at a dose of 40 mg twice daily or a matching placebo tablet twice daily during the Double-Blind period. Following this, there will be an open-label treatment phase to further evaluate safety, tolerability, and effectiveness. All treatments are given alongside the patient’s existing mood stabilizer and/or atypical antipsychotic therapy. Throughout the study, participants will be regularly assessed for changes in depression symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS) from Day 1 through Week 6. Researchers will monitor safety and tolerability during both the double-blind and open-label phases. The study involves ongoing compliance with assessments and procedures to track treatment effects and participant well-being.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are evaluating how well proton beam radiation therapy compares with intensity modulated photon radiotherapy in treating patients with stage I to IVA esophageal cancer. This phase III trial aims to determine if proton beam therapy can improve overall survival and reduce serious heart and lung side effects compared to photon therapy. The study also looks at symptom impact, quality of life, treatment costs, response rates, and hospitalization length between the two treatments. Participants are randomly assigned to receive either proton beam therapy or intensity modulated photon therapy, both given in 28 sessions over 5.5 weeks alongside chemotherapy. Chemotherapy options include carboplatin/paclitaxel, FOLFOX/CAPOX, or docetaxel/fluorouracil regimens, selected by the patient and physician. After completing chemoradiation, patients may have surgery to remove the tumor if it is safe and feasible. During the study, blood samples and imaging scans such as PET/CT or CT are collected to monitor progress. Patients are followed every 3 to 6 months for three years and then yearly to track survival, side effects, and disease status. Researchers also assess patient-reported symptoms and quality of life. The main outcomes measured are overall survival and the occurrence of serious heart and lung side effects related to treatment over up to eight years. Additional assessments include immune cell levels, disease recurrence, and treatment toxicity.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are evaluating two digital mindfulness meditation programs to support mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III trial focuses on women diagnosed with breast cancer at age 50 or younger who have completed their main cancer treatments at least six months ago. The study aims to compare a live, instructor-led online program to a self-paced app-based program and also to explore factors that might influence how well these interventions work, including psychological distress levels and social factors like race and education. Participants will be assigned to one of three groups: a live online Mindful Awareness Practices (MAPs) program delivered over Zoom, a self-paced MAPs digital app, or a meditation-only control group. The live online program includes guided meditations, exercises to manage pain and emotions, and cultivating kindness, with daily home practice increasing from 5 to 20 minutes. The app program unlocks lessons sequentially as participants progress. Meditation use will be tracked across all groups to measure engagement. During the study, participants will report depressive symptoms two weeks after completing the intervention. Researchers will also collect information on emotion regulation strategies and social determinants of health, and monitor how much participants practice mindfulness to understand the programs' effects. The total intervention lasts six weeks, and participants must be able to use a digital device and communicate in English or Spanish. Safety and participation are closely monitored throughout the study.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating treatment preference and satisfaction among adults in the United States diagnosed with schizophrenia who are prescribed xanomeline and trospium chloride (X/T) therapy. The study aims to understand how patients feel about their medication and how satisfied they are with their treatment experience. Participants will receive xanomeline and trospium chloride (X/T) therapy according to the product label. This treatment is being observed in a real-world setting without modifications, focusing on how patients use and respond to this medication combination. During the study, participants will report their medication preference through the Preference of Medication (POM) questionnaire at Month 1, Month 3, and Month 6. Treatment satisfaction will also be measured using the Medication Satisfaction Questionnaire (MSQ) at baseline and at Months 1, 3, and 6. Participants will provide their responses either electronically or on paper, in English or Spanish, over a period of at least six months.

Researchers are evaluating the safety and effectiveness of preoperative radiation therapy using the GammaPod machine for early-stage breast cancer in women over 45 years old. The GammaPod is specially designed to focus radiation precisely on the tumor area within the breast, reducing exposure to surrounding tissues. This study aims to find a safe dose level of single-fraction radiation before lumpectomy surgery and to assess cosmetic effects and quality of life after treatment. Participants will receive one of four increasing dose levels of focused radiation using the GammaPod before their lumpectomy surgery. The breast is held securely in place during treatment with a special breast cup system that has been tested for comfort and positioning accuracy. This preoperative radiation approach is being studied to determine the best dose that balances treatment effectiveness and skin appearance. During the study, participants will undergo imaging tests including CT and MRI to evaluate tumor size and location. Researchers will monitor side effects and cosmetic changes using patient and physician questionnaires, photo software analysis, and quality of life assessments. The study will track dose-limiting toxicities over five years to establish the maximum tolerated radiation dose. Total participation includes treatment, surgery, and long-term follow-up to ensure safety and outcomes.