Forest City

Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

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 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 investigating whether observation is as effective as continuing pembrolizumab treatment in patients with early-stage triple-negative breast cancer who achieved a complete response after preoperative chemotherapy combined with pembrolizumab. This phase III trial aims to evaluate recurrence-free survival and quality of life, as well as the value of reducing immunotherapy treatment after surgery in these patients. The study also examines differences in adverse events, overall survival, and financial impacts between treatment approaches. Participants are randomly assigned to one of two groups after completing neoadjuvant chemotherapy with pembrolizumab and surgery. One group receives pembrolizumab intravenously as adjuvant therapy, while the other group undergoes observation without further treatment. Both groups have tumor biopsies and blood samples collected on study and during follow-up. Additional assessments include questionnaires and quality-of-life evaluations. During the study, researchers monitor participants for up to 10 years to measure recurrence-free survival. They assess quality of life using validated tools, track adverse events, and evaluate financial toxicity and work productivity. The study includes tumor tissue analysis, blood sample collection, and patient-reported outcomes to understand the long-term effects and value of treatment de-escalation in breast cancer care.

Researchers are evaluating the effectiveness of using brain magnetic resonance imaging (MRI) scans alone compared to combining MRI scans with prophylactic cranial irradiation (PCI) in treating patients with small cell lung cancer (SCLC). This phase III trial aims to determine if MRI surveillance alone is not worse than adding PCI in terms of overall survival. The study also looks at cognitive function, brain metastasis-free survival, and treatment side effects among patients with limited or extensive-stage SCLC. Participants are randomly assigned to one of two groups. One group receives PCI, which is radiation therapy focused on the brain, given over two weeks for 20 minutes per day, five days a week, along with scheduled MRI scans at 3, 6, 9, 12, 18, and 24 months. The other group undergoes MRI scans at the same intervals without receiving PCI. Both groups are monitored closely through these MRI scans to track any spread of cancer to the brain. During the study, patients will have regular MRI scans, cognitive assessments, and evaluations of side effects and survival outcomes up to two years after randomization. Blood samples will be collected for future research. Researchers will monitor overall survival, cognitive failure rates, and brain metastasis occurrence, aiming to understand if avoiding PCI might reduce side effects without compromising survival. Participant involvement includes multiple scheduled scans and tests over a two-year follow-up period.

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 that has spread to nearby tissues or lymph nodes. This phase III trial compares SBRT combined with conventional image guided radiation therapy (IGRT), chemotherapy, and immunotherapy or targeted therapy versus the usual treatment alone. The usual chemotherapy involves drugs like cisplatin, carboplatin, paclitaxel, nab-paclitaxel, pemetrexed, and etoposide. Immunotherapy with durvalumab or targeted therapy with osimertinib is also given after chemotherapy, aiming to interfere with tumor growth and spread. Patients are randomly assigned to one of two treatment groups. In the control group, patients receive conventional IGRT with weekly or every-3-week chemotherapy followed by immunotherapy with durvalumab or targeted therapy with osimertinib. In the experimental group, patients receive SBRT to the primary tumor plus conventional IGRT to nodal metastases, combined with the same chemotherapy and consolidation therapies as the control group. Radiation therapies are delivered with precision to minimize damage to healthy tissue. Follow-up imaging with CT and/or PET/CT scans are performed during and after treatment. Participants undergo physical exams, imaging scans, pulmonary function tests, and quality of life assessments before, during, and after treatment. Researchers monitor overall survival and progression-free survival for up to eight years. They also track tumor response, local control, treatment side effects, lung function changes, and patient-reported outcomes. Follow-up visits occur every three months for one year, every six months for years two and three, and yearly thereafter to assess long-term effects and safety.

Researchers are evaluating the effectiveness of adding radiation therapy to the usual immune therapy treatment with atezolizumab in people with extensive stage small cell lung cancer that has spread beyond the lungs. This phase II/III trial aims to compare progression-free survival and overall survival between patients receiving atezolizumab alone and those receiving atezolizumab combined with radiation therapy. The study also examines treatment side effects, the effect of radiation on tumor size and number, and the relationship between tumor burden before treatment and patient outcomes. Participants are randomly assigned to one of two groups. One group receives atezolizumab through an intravenous infusion every 21 days. The other group receives the same atezolizumab treatment plus radiation therapy once daily for five days each week over five weeks. During the study, patients undergo various imaging scans including PET/CT, CT, and MRI to monitor their cancer. Blood and tissue samples are also collected. After finishing treatment, patients are followed every three months for two years, then every six months for three years, and annually thereafter. Throughout the trial, researchers assess how long patients live without their cancer worsening and overall survival up to six years after starting treatment. They monitor the safety and side effects of the treatments, using imaging to evaluate tumor response. The study involves regular health exams, scans, and laboratory tests to carefully track each patient's progress and reactions to the therapies over time.

Researchers are evaluating patients who have had surgical removal of bladder, kidney, ureter, or urethra due to muscle-invasive urothelial cancer. This phase II/III trial studies whether a blood test measuring circulating tumor DNA (ctDNA) can identify patients at higher risk of cancer returning, and whether immunotherapy treatments including nivolumab and relatlimab can help prevent recurrence and prolong survival. The study aims to determine if ctDNA levels after surgery can guide the need for additional immunotherapy treatment and compare outcomes between different treatment approaches. Patients are assigned to one of two groups based on their ctDNA test results after surgery. Those with positive ctDNA (Cohort A) are randomly assigned to receive either nivolumab alone or nivolumab combined with relatlimab via intravenous infusion every 28 days for up to 12 cycles. Patients with negative ctDNA (Cohort B) are randomly assigned to receive either immediate nivolumab treatment or ctDNA surveillance with treatment starting only if ctDNA becomes positive. Throughout the study, participants undergo tissue and blood sample collections, imaging scans such as CT or MRI, and may have cystoscopy procedures. Participants are closely monitored during treatment and after completing therapy with follow-up visits scheduled at multiple time points up to 248 weeks. Researchers assess the clearance of ctDNA, overall survival, disease-free survival, and quality of life using questionnaires. Safety is also evaluated, and the study explores associations between ctDNA changes and patient outcomes. This comprehensive monitoring helps to understand the benefits and risks of the immunotherapy treatments and the role of ctDNA in guiding therapy for urothelial cancer patients.

Researchers are evaluating alternative dosing strategies for CDK4/6 inhibitors to help patients aged 65 years or older with Metastatic Breast Cancer (MBC) better tolerate side effects and continue treatment longer. This Phase 3 study compares the standard approved dosing of palbociclib or ribociclib with a titrated dosing approach that starts at a lower dose and increases as tolerated. The study also aims to personalize treatment by assessing patient-reported outcomes and baseline factors such as age and frailty scores. Participants will receive either the indicated dosing regimen—palbociclib 125 mg or ribociclib 600 mg orally daily on days 1-21 of a 28-day cycle—or a titrated dosing regimen starting at lower doses of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) with dose escalation if well-tolerated. All treatments are given in combination with endocrine therapy chosen by the patient and provider, either an aromatase inhibitor or fulvestrant. Telehealth visits and remote consenting are permitted according to institutional guidelines. During the study, researchers will monitor time to treatment discontinuation up to 48 months. Participants will be evaluated through laboratory tests, patient-reported outcomes, and standard assessments of treatment side effects. The study includes subgroup analyses for ages 65-74 versus 75 and older and tracks safety and tolerability to understand how different dosing strategies affect treatment continuation and patient experience.