Bay Shore

Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan (R-DXd) in people with platinum-resistant, high-grade ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This study includes both Phase 2 and Phase 3 parts, aiming to determine the best dose of R-DXd and compare it with standard chemotherapy treatments. R-DXd is designed to target CDH6, a protein found in high amounts on tumor cells, to deliver its treatment directly to the cancer. Participants will be randomly assigned to receive intravenous R-DXd at different doses every three weeks or to receive chemotherapy chosen by the doctor, including paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan. The Phase 2 part focuses on finding the recommended dose based on safety and response, while Phase 3 compares R-DXd at the recommended dose against chemotherapy to further assess its effects. Throughout the study, participants will undergo scans to measure tumor response and various assessments to monitor symptoms, side effects, and other health factors. Researchers will track outcomes like tumor shrinkage, survival without disease progression, overall survival, treatment side effects, and quality of life measures for up to 40 months. Participants will have regular visits for treatment, lab tests, and symptom evaluations to ensure close monitoring during the trial.

Researchers are evaluating the safety and effectiveness of a combination treatment using carboplatin and mirvetuximab soravtansine in adult women with advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that expresses folate receptor alpha (FRb1). This single-arm Phase 2 study focuses on patients with stage III or IV disease who have measurable tumors and high FRb1 expression. The investigational drug mirvetuximab soravtansine is designed to target and kill cancer cells carrying this receptor. Participants will receive intravenous infusions of mirvetuximab soravtansine combined with carboplatin on the first day of each 21-day cycle. Bevacizumab may also be given based on the investigator's decision. This treatment will continue for 6 to 9 cycles over the course of the study, which is expected to last approximately three years. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, and scans to monitor their response to treatment and any side effects. Researchers will evaluate tumor response through imaging and other measures over up to three years, also tracking disease control, progression-free survival, and symptom changes. Safety will be closely monitored throughout the study period.

Researchers are evaluating two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 gene mutations. This trial compares bilateral salpingectomy, which removes the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The study aims to see if the less extensive surgery is nearly as effective at lowering cancer risk and assesses effects on quality of life, menopausal symptoms, sexual function, and medical decision making. Participants choose between two groups: one undergoing bilateral salpingectomy with possible delayed removal of ovaries, and the other undergoing immediate removal of both fallopian tubes and ovaries. Before surgery, patients have pelvic or transvaginal ultrasounds or pelvic MRIs and blood samples collected. Follow-up visits occur at 10 to 60 days, 6, 12, and 24 months after surgery, then annually for up to 20 years. During the study, researchers will monitor the development of ovarian, primary peritoneal, or fallopian tube cancers over 20 years. They will also assess quality of life, cancer-related distress, menopausal and estrogen deprivation symptoms, sexual dysfunction, medical decision making, and adverse events up to 24 months after surgery. Blood samples and tissue are collected for future research. The long-term follow-up helps understand both cancer risk and patient well-being after surgery.

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 studying advanced stomach or esophageal adenocarcinoma to see if adding the drug nivolumab to the usual treatment of paclitaxel and ramucirumab improves outcomes for patients. This phase II/III trial compares the combination of nivolumab, paclitaxel, and ramucirumab with paclitaxel and ramucirumab alone. The study aims to assess progression-free survival and overall survival, while also evaluating response rates, disease control, safety, and quality of life. Participants are randomly assigned to one of two groups. One group receives nivolumab intravenously on day 1 of each 28-day cycle, along with ramucirumab on days 1 and 15, and paclitaxel on days 1, 8, and 15. The other group receives ramucirumab and paclitaxel on the same schedule without nivolumab. Treatments continue unless the disease progresses or unacceptable side effects occur. Patients may also have optional blood tests, CT scans, and MRIs during the study. Throughout the trial, participants undergo regular imaging scans and optional blood sample collection to monitor disease status. After treatment ends, follow-up visits occur at 30, 60, and 90 days, then every 6 months for up to 3 years to assess survival and health. Researchers also collect patient-reported outcomes related to symptoms and quality of life during the study period.

Researchers are evaluating camizestrant, a new oral drug, compared to standard adjuvant endocrine therapies for patients with early breast cancer that is estrogen receptor positive and HER2 negative. This trial focuses on patients at intermediate-high or high risk for the cancer returning who have completed local treatments like surgery, with or without chemotherapy. The study is a Phase III open-label trial sponsored by AstraZeneca, aiming to see if camizestrant improves invasive breast cancer-free survival over a planned treatment duration of seven years. Participants will be randomly assigned to one of two treatment groups: one receiving standard endocrine therapy chosen by the doctor (including aromatase inhibitors such as exemestane, letrozole, or anastrozole, or tamoxifen) with or without abemaciclib, and the other receiving camizestrant with or without abemaciclib. Treatments are taken orally, and both groups are followed for up to 10 years from the last patient's randomization to monitor outcomes and safety. During the study, participants will have regular assessments to monitor invasive breast cancer-free survival, overall survival, and other outcomes like distant relapse-free survival and quality of life. Safety evaluations include tracking side effects using established criteria and patient-reported measures. Pharmacokinetics of camizestrant will be studied for six months, with adverse events monitored up to 28 days after the last treatment dose. The total involvement can last up to 14 years including treatment and follow-up periods.

Researchers are evaluating treatment options for patients with nasal and paranasal sinus squamous cell carcinoma that can be surgically removed. This phase II randomized trial compares chemotherapy given before surgery and radiation therapy to surgery and radiation therapy alone. The study aims to see if giving chemotherapy first can shrink tumors and help preserve important nearby structures like the skull base and orbit, while also looking at overall survival and progression-free survival. Participants are randomly assigned to one of two groups. One group has surgery followed by radiation therapy, with additional chemotherapy if certain risk factors are found after surgery. The other group receives chemotherapy first, then surgery, followed by radiation therapy with possible additional chemotherapy. Chemotherapy drugs studied include docetaxel, cisplatin, and carboplatin, all given through intravenous infusions. Radiation therapy is delivered using image-guided intensity-modulated radiation therapy (IMRT) daily for several weeks. During the study, participants undergo scans like MRI and PET/CT to assess tumor response and help predict outcomes. They are monitored regularly for side effects and treatment effects, with follow-up visits every three months for up to two years and then every six months up to five years. Researchers also collect data on tobacco use and its impact on treatment outcomes. The main outcomes measured are the rate of preserving the skull base and orbit and overall survival over five years.

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 treatments for symptomatic unilateral iliofemoral deep vein thrombosis (DVT), comparing the ClotTriever System, a mechanical thrombectomy device, to standard anticoagulation therapy. This prospective, multicenter, randomized controlled trial aims to understand which approach better achieves and maintains vessel openness, tracking clinical outcomes and patient details through six months. About 300 participants will be enrolled and randomly assigned to one of the two treatment groups. Participants in the ClotTriever Intervention Arm will receive the mechanical thrombectomy procedure using the ClotTriever System. Those in the Conservative Medical Management Arm will receive anticoagulation therapy alone, including approved drugs such as Heparin, Coumadin, Rivaroxaban, or Apixaban. The study involves two main treatment approaches, with monitoring continuing through the six-month follow-up period to assess treatment effects and safety. During the study, participants will undergo assessments to collect data on demographics, comorbidities, DVT diagnosis, and treatment details. Clinical outcomes will be measured at intervals up to 180 days, focusing on a composite clinical endpoint using a win ratio method and evaluating post-thrombotic syndrome severity. Follow-up visits will monitor health status, treatment adherence, and any complications. The total duration of participation will extend through the six-month post-treatment period.

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.