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Found 3 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 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 types of radiation therapy, fractionated stereotactic radiosurgery FSRS and the usual stereotactic radiosurgery SRS, in treating patients whose cancer has spread to the brain from other parts of the body. This phase III study aims to see if FSRS, which delivers radiation over three sessions, improves the time before the tumor returns compared to SRS, which delivers a single high-dose radiation treatment. The study also looks at other outcomes such as overall survival, brain progression, and side effects of the treatments. Participants are randomly assigned to one of two groups. One group receives a single session of SRS lasting 30 to 90 minutes, while the other group receives FSRS divided into three sessions of the same length. Both groups undergo computed tomography CT and magnetic resonance imaging MRI scans during the study. After treatment, patients are followed closely with regular check-ups every three months for the first year, then every four months for the second year, and every six months for the following three years. During the study, participants will have imaging scans to monitor tumor response and progression. Researchers will measure how long it takes for the tumor to grow back, progression of cancer in the brain, overall survival, and any radiation-related side effects. Safety is monitored for up to two years, and tumor outcomes are tracked for up to five years. This thorough follow-up helps to understand the long-term effects of the two radiation methods in patients with brain metastases.

Age: 18Years +All GendersPhase 3
270 locations