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Found 5 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 50Years - 70YearsAll GendersPhase 3
832 locations
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Actively Recruiting

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.

Age: 18Years - 60YearsFEMALEPhase 3
1259 locations
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Actively Recruiting

Researchers are evaluating how well radiation therapy with or without the chemotherapy drug cisplatin works in treating patients who have stage III-IVA squamous cell carcinoma of the head and neck after surgery. This phase II trial aims to understand if adding cisplatin to radiation therapy improves disease-free survival and to explore the role of p53 mutations as a biomarker for treatment benefit. The study also assesses the safety and side effects of these treatments and looks for other genetic changes that might guide new therapies. Participants are randomly assigned to one of two groups. One group receives intensity-modulated radiation therapy IMRT once daily, five days a week for six weeks. The other group receives the same radiation schedule plus weekly intravenous cisplatin for six weeks. After treatment, participants are followed up every six months for three years and then yearly for seven years to monitor outcomes. During the study, patients will have assessments including surgical tumor tissue analysis for p53 mutation, imaging scans to check for cancer spread, and blood tests to monitor health and organ function. Researchers will track disease recurrence, new tumors, or death for up to 10 years. Side effects will be recorded during treatment. The total study participation includes treatment over six weeks followed by long-term follow-up visits lasting up to 10 years.

Age: 18Years +All GendersPhase 2
676 locations
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Actively Recruiting

Researchers are comparing two treatments for patients with 5 or more brain metastases stereotactic radiosurgery SRS and hippocampal-avoidant whole brain radiotherapy HA-WBRT combined with the drug memantine. This study aims to find out if SRS is better, the same, or worse than the usual treatment approach, which is whole brain radiation therapy alone. The study will assess how these treatments affect cancer control, overall survival, memory, quality of life, and cancer-related symptoms. Participants will be randomly assigned to receive either SRS, which delivers a high dose of radiation to specific small areas in the brain in a single session, or HA-WBRT plus memantine. HA-WBRT involves radiation to the whole brain while avoiding the hippocampus area to protect memory, given in 10 radiation fractions totaling 30Gy. Memantine is given starting at 5 mg and increased weekly to a target dose of 20 mg daily in divided doses. Treatment is provided as an outpatient procedure. During the study, participants will undergo regular assessments including MRI scans, neurocognitive testing, quality of life questionnaires, and blood tests to measure biomarkers. Researchers will monitor survival, brain cancer control, cognitive function, side effects, and treatment costs over 4.5 years. The study also includes collecting imaging and blood samples to understand treatment effects and brain changes. Participants are expected to be available for treatment, follow-up, and completing questionnaires throughout the study period.

Age: 18Years +All GendersPhase 3
86 locations
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Actively Recruiting

Researchers are investigating treatments for men with prostate cancer that has returned after surgery, focusing on those who experience a rise in prostate-specific antigen PSA levels, indicating biochemical recurrence. The study examines whether adding enhanced systemic therapy apalutamide combined with abiraterone and prednisone to standard care, which includes prostate radiation therapy and short-term androgen deprivation, improves outcomes. Additionally, for patients whose cancer has spread beyond the pelvis as detected by PET imaging, the study evaluates the benefit of adding metastasis-directed radiation therapy. Participants undergo baseline PETCT or PETMR scans to determine the extent of cancer spread. Based on these results, they are randomized into one of four treatment arms standard radiation with androgen deprivation, enhanced therapy including apalutamide, or enhanced therapy plus targeted radiation for metastatic disease. Treatments involve various forms of radiation therapy, androgen deprivation drugs, and oral apalutamide, administered over six months in the absence of disease progression or unacceptable side effects. Some patients may receive repeat PET scans to assess treatment response. During the study, participants have scheduled assessments including imaging, blood tests measuring PSA levels, and quality-of-life questionnaires over up to ten years. Follow-up visits occur every three months for the first two years, then less frequently up to ten years. Researchers monitor progression-free survival, overall survival, event-free survival, PSA progression, adverse events, and quality of life measures including cognitive function and fatigue. This long-term monitoring aims to determine the effectiveness of the added therapies compared to standard treatment alone.

Age: 18Years +MALEPhase 3
342 locations