Forest City

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 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 investigating whether adding the drug Docetaxel to the usual hormone treatments, Androgen Deprivation Therapy ADT and Androgen-Receptor Pathway Inhibitor ARPI, can better control metastatic castration sensitive prostate cancer in men who have not responded optimally to initial hormone therapy. This phase III, international, open-label, randomized trial seeks to compare the effectiveness of this combined approach against the standard hormone therapy alone. Participants will be randomly assigned to receive either the standard hormone therapy with ADT plus ARPI or the same hormone therapy combined with Docetaxel chemotherapy. The trial focuses on men with metastatic prostate cancer who continue to have elevated PSA levels after 6 to 12 months of hormone-targeting treatment. Treatments are administered according to physician choice and assignment, and the study evaluates outcomes over a long period. During the trial, participants will be closely monitored with assessments including PSA levels and clinical progression over 39 months. Researchers will measure overall survival as the primary outcome, along with secondary outcomes such as PSA progression, PSA response, PSA kinetics, and progression-free survival. Participants must be accessible for treatment and follow-up to allow for complete documentation of treatment effects and adverse events throughout the study duration.

Researchers are evaluating two digital mindfulness-based interventions to improve mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III randomized trial focuses on women diagnosed at or before age 50, who completed primary cancer treatments at least six months earlier. The study aims to compare the effectiveness of live instructor-led sessions via Zoom and a self-paced app-based program, exploring which approach best supports psychological health in this population. Participants will be assigned to one of three groups the live online mindfulness sessions MAPs LO conducted weekly for 6 weeks via Zoom, the MAPs App delivering the same content in shorter sessions over 6 weeks, or a meditation-only control group accessing guided audio meditations. Both English and Spanish speakers can participate in the live online and meditation groups, while the app is only available in English. Tablets and internet hotspots are provided if needed. All groups have access to the UCLA MARC mindfulness meditation app throughout the 6-month follow-up. During the study, participants will attend weekly sessions for the live group or engage with app content at home, with usage tracked to measure intervention dose. Researchers will assess depressive symptoms shortly after the intervention and again up to 6 months later, along with fatigue symptoms. They will also investigate factors influencing intervention effects, such as baseline distress and social determinants, and evaluate the cost-effectiveness of the programs. The total study duration includes a 6-week intervention period plus follow-up assessments out to 6 months.

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 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 whether adding stereotactic body radiation therapy SBRT to the usual treatment improves outcomes for patients with locally advanced, inoperable non-small cell lung cancer NSCLC that has spread to nearby tissues or lymph nodes. This phase III trial compares the effect of SBRT combined with conventional image guided radiation therapy IGRT, chemotherapy, and immunotherapy or targeted therapy against the usual treatment alone. The study aims to assess overall survival, progression-free survival, tumor response, lung function, quality of life, and treatment-related side effects. Participants are randomly assigned to one of two groups. In the first group, patients receive conventional IGRT and chemotherapy with drugs such as paclitaxel, carboplatin, pemetrexed, cisplatin, or etoposide during radiation, followed by immunotherapy with durvalumab or targeted therapy with osimertinib. The second group receives SBRT combined with conventional IGRT and similar chemotherapy, followed by the same immunotherapy or targeted therapy options. Both groups undergo CT andor PETCT scans during follow-up. Chemotherapy schedules vary by drug, including weekly or every 21-day dosing during radiotherapy, with consolidation treatments lasting up to one year. Throughout the study, participants undergo assessments including lung function tests FEV1 and DLCO, quality of life questionnaires, imaging scans, and monitoring for side effects using standard criteria. Follow-up visits occur every three months for the first year, every six months during years two and three, and annually thereafter, continuing for the duration of the study. Biospecimens and advanced imaging data are collected for exploratory analyses, including development of machine learning tools for radiation planning. Overall survival and progression-free survival are the primary outcomes measured up to eight years after randomization.

This trial studies patients with extensive stage small cell lung cancer that has spread outside the lung. It compares the effects of adding radiation therapy to the usual maintenance treatment with atezolizumab versus using atezolizumab alone. Researchers aim to see if combining radiation with immunotherapy can extend the time before the cancer grows or spreads, and improve overall survival. The study is a phase IIIII randomized trial sponsored by the National Cancer Institute. Participants are randomly assigned to one of two groups. One group receives atezolizumab intravenously every 21 days. The other group receives the same atezolizumab treatment plus radiation therapy once daily on days 1 through 5 during the first five weeks. Both groups undergo imaging scans including PETCT, CT, and MRI, as well as blood and tissue collections during the trial. Throughout the study, participants are monitored closely with scans and lab tests. After treatment ends, follow-up visits occur every 3 months for 2 years, then every 6 months for 3 years, and annually thereafter. Researchers measure progression-free survival and overall survival up to 6 years, along with side effects and how tumor characteristics may affect outcomes. The trial evaluates the benefits and risks of combining radiation with atezolizumab for this cancer.

Researchers are studying patients with muscle-invasive urothelial cancer of the bladder, kidney, ureter, or urethra who have had surgery to remove the cancer. The study aims to see if a blood test measuring circulating tumor DNA ctDNA can identify patients at higher risk of cancer returning and who might benefit from additional immunotherapy. This trial evaluates the use of immunotherapy drugs nivolumab and relatlimab to determine if they can improve survival and delay cancer progression after surgery. Participants are divided into two groups based on their ctDNA blood test results. Those with positive ctDNA are randomly assigned to receive either nivolumab alone or nivolumab combined with relatlimab, given intravenously every 28 days for up to 12 cycles. Those with negative ctDNA are randomized to immediate nivolumab treatment or surveillance with regular ctDNA monitoring and nivolumab treatment if ctDNA becomes positive. Throughout the trial, patients undergo tissue and blood sample collection, imaging scans like CT or MRI, and may have cystoscopy. During the study, participants have regular assessments including blood tests, imaging, and quality of life questionnaires. Researchers track ctDNA clearance, disease-free survival, overall survival, and adverse events for up to five years after treatment. Follow-up visits occur at specific weeks up to nearly five years post-treatment to monitor long-term outcomes and safety. The trial also explores the relationship between ctDNA levels and cancer progression along with the cost and value of different treatment approaches.

Researchers are evaluating different dosing strategies of CDK46 inhibitors in patients aged 65 years or older with Hormone Receptor Positive HR and HER2-negative Metastatic Breast Cancer MBC. The study aims to compare the time patients remain on treatment using the standard approved dosing versus a titrated dosing approach that starts at a lower dose and increases if well tolerated. This Phase 3, randomized trial also explores patient-reported outcomes and baseline factors to help personalize treatment for older patients. Participants will choose either palbociclib or ribociclib as their CDK46 inhibitor and select an endocrine therapy partner, either an aromatase inhibitor or fulvestrant. They will be randomized to one of two groups Arm 1 receives the indicated dosing regimen starting at the full approved dose, while Arm 2 starts at a lower dose with potential escalation based on tolerance. Treatment cycles are 28 days long, with the CDK46 inhibitor taken daily for 21 days per cycle. Throughout the study, participants will be monitored for treatment duration, side effects, quality of life, dose adjustments, and healthcare use. Data will be collected up to 48 months, including patient questionnaires and clinical assessments to track tolerability and outcomes. Telehealth visits and remote consenting are permitted to facilitate participation. The study seeks to find dosing strategies that help older patients tolerate treatment longer and improve their clinical benefit.