North Wilkesboro

Researchers are evaluating survival outcomes for patients with early stage cervical cancer undergoing either robotic-assisted laparoscopy or open hysterectomy with lymph node assessment. This multi-center, randomized trial tests the hypothesis that robotic hysterectomy with tumor containment before colpotomy is not inferior to abdominal hysterectomy regarding disease-free survival. The study focuses on patients with specific cervical cancer stages and tumor sizes, aiming to compare surgical approaches. Participants are randomly assigned to one of two groups: the standard open surgery group performing radical or simple hysterectomy using established techniques with vaginal closure over the tumor before colpotomy, and the robotic surgery group using minimally invasive robotic-assisted hysterectomy with vaginal closure prior to intracorporeal colpotomy. Surgeons perform thorough intraoperative assessments for metastatic disease, and certain patients with confirmed metastases are excluded from final analysis. Detailed surgical data and complications are recorded for all cases. During the study, participants will undergo preoperative assessments, surgery, and follow-up evaluations. Researchers will monitor survival over 36 months as the primary outcome, documenting operative time, findings, blood loss, and complications. Patients will be followed to assess disease-free survival, with attention to surgical outcomes and safety. The total duration of participation includes the surgery and long-term survival monitoring to compare the effectiveness of the two surgical methods.

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 evaluating whether adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival in premenopausal women with early-stage, estrogen receptor-positive, HER2-negative breast cancer. This Phase III trial focuses on patients with specific 21-gene recurrence scores and aims to clarify the best treatment approach for younger women, who face higher risks despite current therapies. The study addresses the uncertainty about the role of ovarian suppression combined with chemotherapy versus ovarian suppression alone in this patient group. Participants are randomly assigned to one of two treatment groups: one receiving ovarian function suppression with an aromatase inhibitor for 5 years, and the other receiving adjuvant chemotherapy followed by the same ovarian suppression and aromatase inhibitor regimen. The choice of drugs and dosing schedules for the aromatase inhibitor and GnRH agonist are determined by the investigators, with common options including monthly or every-three-months administration of agents like goserelin, leuprolide, or triptorelin. Endocrine therapy may continue beyond five years at the investigator’s discretion, and bilateral oophorectomy can substitute for ovarian suppression if preferred. Throughout the trial, participants will be closely monitored over 11 years for outcomes including invasive breast cancer-free survival, overall survival, distant recurrence-free interval, and breast cancer-free interval. Evaluations of menopausal symptoms and pain during aromatase inhibitor therapy will be conducted one year after randomization. The study involves regular assessments and follow-up to track the effectiveness and impact of the treatments on patients’ health and quality of life.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase II/III 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.

Researchers are evaluating the combination of bevacizumab and osimertinib versus osimertinib alone as an initial treatment for patients with advanced non-small cell lung cancer (NSCLC) that has spread beyond the lungs and has specific mutations in the EGFR gene. This phase III trial aims to understand if adding bevacizumab, which inhibits blood vessel growth to tumors, can control cancer longer and improve survival compared to osimertinib alone, which blocks EGFR involved in tumor cell growth. Participants are randomly assigned to one of two groups. One group receives daily oral osimertinib every 21 days, while the other group receives the same osimertinib dose plus an intravenous bevacizumab infusion every 21 days. Treatment continues until disease progression or unacceptable side effects occur. During the study, patients undergo various imaging tests such as echocardiography, multigated acquisition scan, computed tomography, and possibly magnetic resonance imaging, along with blood and urine sample collections. After treatment ends, patients are followed every three months for up to 10 years to monitor their health and disease status. The main outcome measured is progression-free survival, tracking the time until the cancer worsens or death occurs. Secondary outcomes include overall survival, response rates, and effects on central nervous system progression. Safety is also assessed through adverse event monitoring. This long-term follow-up helps researchers understand the lasting effects of the treatments.

Researchers are evaluating whether brain MRI scans alone can effectively monitor small cell lung cancer compared to the combination of MRI scans with preventive brain radiation called prophylactic cranial irradiation (PCI). This phase III trial aims to see if using MRI surveillance alone can maintain overall survival and reduce side effects, potentially prolonging patients' lives. The study also looks at cognitive function, brain metastasis-free survival, and treatment toxicities. Participants are randomly assigned to one of two groups. One group receives PCI radiation therapy to the brain over two weeks along with scheduled MRI scans at 3, 6, 9, 12, 18, and 24 months. The other group only undergoes MRI scans at the same time points without PCI. Some patients in the PCI group may receive hippocampal avoidance radiation to spare cognitive function. During the study, participants undergo regular MRI scans and cognitive testing to track brain health and cancer spread. Researchers monitor survival rates, cognitive failure-free survival, brain metastases occurrence, and adverse events for up to two years after randomization. Blood samples may be collected for banking. The total follow-up includes multiple visits and assessments to evaluate the effects of MRI surveillance alone versus combined PCI and MRI monitoring.

Researchers are evaluating the optimal duration of HER2-targeted therapy for patients with early-stage HER2-positive breast cancer who have achieved a complete response after preoperative chemotherapy with trastuzumab. This phase III trial compares 6 months versus 12 months of combined neoadjuvant and adjuvant HER2 blockade to see if shorter therapy is as effective and to assess quality of life differences. The study also aims to evaluate side effects, recurrence rates, overall survival, and patient-reported outcomes related to symptoms and quality of life up to 10 years post-treatment. Participants are randomly assigned to one of two groups. One group receives trastuzumab and possibly pertuzumab intravenously or subcutaneously every 21 days for up to 17 cycles (about 12 months), while the other group receives the same treatment for up to 9 cycles (about 6 months). Treatments are given unless disease progresses or unacceptable toxicity occurs. Throughout the trial, participants undergo heart function tests (echocardiography or MUGA), breast imaging (mammography, ultrasound, or MRI), and may optionally provide blood and tissue samples. During the study, participants have regular assessments including quality of life questionnaires and monitoring for side effects. After treatment completion, follow-up visits occur every 6 months for 5 years or until cancer recurrence, then annually until 10 years from registration. Researchers measure recurrence-free survival, quality of life scores, adverse events, and survival outcomes. This long-term follow-up helps evaluate the lasting impact of shorter versus longer HER2-targeted therapy.

Researchers are evaluating treatments 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 adding stereotactic body radiation therapy (SBRT) to the usual treatment, which includes conventional image guided radiation therapy (IGRT), chemotherapy, and immunotherapy with durvalumab or targeted therapy with osimertinib. The study aims to see if adding SBRT improves overall survival and progression-free survival compared to the usual treatment alone. Participants are randomly assigned to one of two groups. One group receives conventional IGRT along with chemotherapy drugs such as paclitaxel, carboplatin, pemetrexed, cisplatin, or etoposide, followed by consolidation immunotherapy with durvalumab or targeted therapy with osimertinib. The other group receives SBRT followed by conventional IGRT and the same chemotherapy and consolidation therapies. SBRT delivers high-dose, precise radiation to the primary tumor over a shorter period, potentially reducing damage to healthy tissue. Both groups undergo periodic CT and PET/CT scans during follow-up. During the study, participants are followed every 3 months for the first year, then every 6 months for years 2 and 3, and annually thereafter for up to 8 years. Researchers assess overall survival, progression-free survival, tumor response, local control, patterns of cancer recurrence, lung function changes, quality of life, patient-reported outcomes, and treatment side effects. Biospecimens and advanced imaging data are collected for exploratory analyses, and safety is monitored throughout the study.

Researchers are evaluating whether high dose chemotherapy combined with the patient's own stem cell transplant improves outcomes compared to observation only in patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy. This phase III trial aims to better understand progression-free survival and overall survival differences between these treatment approaches, as well as relapse and mortality rates over a long-term follow-up of up to 12 years. The study also explores the role of minimal residual disease in treatment benefit. Participants are randomly assigned to one of two groups. One group receives standard observation with regular blood sample collection, optional bone marrow biopsy, and imaging scans such as CT or PET/CT. The other group undergoes stem cell mobilization, leukapheresis, high dose chemotherapy, and autologous stem cell transplantation, alongside the same monitoring procedures. After treatment, patients are monitored every 3 months for 2 years, then every 6 months for 3 years, and yearly thereafter, totaling 12 years from enrollment. During the study, participants undergo blood tests, optional bone marrow sampling, and imaging scans to track disease status. Researchers monitor progression-free survival, overall survival, relapse rates, and mortality. The long follow-up period allows for comprehensive assessment of treatment effects and safety. Participants can expect regular visits for assessments and monitoring throughout their involvement in the trial, which lasts up to 12 years from the date of randomization.