Brunswick

Researchers are evaluating the effect of adding intensity-modulated post-operative radiation therapy I-PORT to standard chemotherapy or immunotherapy in patients with non-small cell lung cancer NSCLC who still have lymph node cancer after surgery. This phase II trial aims to see if I-PORT improves disease-free survival and whether it increases serious heart or lung side effects compared to standard care alone. The study also looks at overall survival, cancer control, and patient-reported symptoms related to heart and lung health. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy or immunotherapy alone, continuing treatment if the cancer does not progress or side effects are manageable. The other group receives I-PORT once daily Monday through Friday for 5 to 6 weeks, starting 4 to 12 weeks after surgery, followed by the same standard chemotherapy or immunotherapy. Imaging scans and blood samples are collected during treatment in both groups. After completing treatment, participants are followed for five years with check-ups every three months for two years, then every six months for three years. During these visits, researchers assess disease recurrence, survival, side effects, and patient symptoms. The study uses various scans including CT, MRI, and FDG-PET, along with blood tests, to monitor participants health and treatment impact over time.

Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase IIIII trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.

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 collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.

This trial investigates treatments for older adults newly diagnosed with acute myeloid leukemia AML who have a specific gene mutation called IDH2. It compares the combination of ASTX727 and venetoclax with or without the addition of enasidenib. The study aims to see if adding enasidenib helps more patients achieve remission by targeting the IDH2 mutation that contributes to leukemia growth. Participants are randomly assigned to one of two groups. One group receives ASTX727, an oral combination of cedazuridine and decitabine, plus venetoclax daily for 28 days in repeated 28-day cycles. The other group receives the same treatment with the addition of enasidenib every day in the cycle. Treatment continues unless the disease worsens or side effects become unacceptable. Throughout the trial, patients undergo blood and bone marrow tests to monitor their response. During the study, participants have regular blood sample collections, bone marrow aspirations, and biopsies to assess disease status and treatment effects. After completing treatment, follow-up visits occur monthly for the first year, then every two months in the second year, every three months in the third year, and every six months up to five years or until death. The main outcome measured is the rate of remission without detectable leukemia after two treatment cycles. Safety and long-term outcomes are also tracked.

Researchers are evaluating a mentorship and education program called COACH-APP to improve advanced practice providers APPs confidence in participating in clinical research. APPs are skilled healthcare professionals involved in cancer care but may not always be integrated into research teams at community oncology sites. This program aims to provide focused education and structured mentorship to better involve APPs in research, potentially enhancing patient care and access to clinical trials. The study compares APPs who receive the COACH-APP intervention, which includes completing a six-module clinical research workshop and five mentoring sessions over 12 months, to APPs who receive education only, with access to the workshop and a clinical trials manual. Mentors and research care team members will also participate to assess the programs impact. The intervention group receives both education and mentorship, while the control group receives education alone. Participants will engage in workshops, mentoring sessions, and surveys over the course of 12 months, with some participating in recorded interviews about their experiences. Researchers will measure changes in research self-efficacy, engagement in research programs, integration within research teams, and practice-level study activity. The study also evaluates the acceptability, feasibility, and appropriateness of the COACH-APP intervention and explores its effects on team functioning and patient access to clinical trials.

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 an online educational program called Current Together After Cancer CTAC to see if it helps colorectal cancer survivors who had surgery receive follow-up care that matches current guidelines. This phase III trial focuses on patients with stage II or III colorectal cancer who have had their tumors surgically removed. The study aims to improve patients knowledge about surveillance, their confidence in managing follow-up care, and satisfaction with the involvement of a supporter in their care. Patients in the trial are randomly assigned to one of two groups. One group and their supporter get access to the CTAC intervention website, which contains educational content and interactive modules related to colorectal cancer surveillance. The other group and their supporter receive access to a general health education website. Participants may review their assigned website as often as they like for up to 16 months. During the study, participants will complete questionnaires at baseline, 3 months, and 16 months to assess knowledge, self-efficacy, cancer worry, preferences, and satisfaction with supporter engagement. Researchers will measure whether patients receive colorectal cancer surveillance aligned with guidelines at 16 months. The study also explores how supporters participation relates to patient outcomes. Participants may be contacted via email or phone for study activities and are encouraged to complete all scheduled assessments.

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 a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.