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Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

This research aims to compare two methods of monitoring pancreatic cysts and to identify biomarkers that may help detect the risk of these cysts turning into pancreatic cancer. The study evaluates whether more frequent monitoring or less frequent monitoring leads to better patient outcomes and explores various blood and imaging biomarkers for improved risk prediction. Participants are observed through two different surveillance approaches that were previously randomized but are now closed to new enrollment. One approach involves lower intensity monitoring with MRI, CT, or endoscopic ultrasound EUS scans spaced out over years, while the other involves higher intensity monitoring with more frequent imaging based on cyst size. Throughout the study, patients may also provide blood samples and undergo biopsies, fine needle aspirations, or surgery as needed. Participants are followed up regularly for five years from registration, with imaging and blood tests at intervals depending on their assigned monitoring method. Researchers collect data on clinical features, anxiety, quality of life, financial distress, healthcare costs, and outcomes such as the development of concerning pancreatic cyst features or pancreatic cancer. The study uses these measures to assess the effectiveness of monitoring strategies and the predictive value of biomarkers.

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 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 studying colorectal cancer CRC in participants aged 45 to 70 who have 1 to 2 non-advanced adenomas, which are small colon polyps without high-risk features. The trial compares two surveillance colonoscopy schedules one group receives colonoscopy at 5 and 10 years after polyp detection, while the other group has colonoscopy only at 10 years. This study aims to provide randomized data to guide optimal timing for follow-up colonoscopies to help reduce CRC incidence and improve clinical practices. Participants are randomly assigned to one of two groups the first group undergoes surveillance colonoscopy at both 5 and 10 years following their qualifying colonoscopy, and the second group undergoes colonoscopy at 10 years only. All colonoscopies, including any unscheduled ones, follow current quality guidelines and institutional preparation standards. The qualifying colonoscopy must have been complete and performed within 4 years before randomization, with all polyps fully removed. During the study, participants will undergo colonoscopies according to their assigned schedules. Researchers will monitor the incidence of colorectal cancer over 10 years as the primary outcome. Participants must be able to understand English or Spanish to complete required procedures. The study may last up to several decades, with ongoing monitoring to assess long-term cancer incidence and the effectiveness of different surveillance intervals.

Researchers are evaluating treatments for patients with high-risk, locally advanced cervical cancer that has spread to nearby tissue or lymph nodes. This Phase III trial compares adding induction chemotherapy with carboplatin, paclitaxel, and pembrolizumab before standard chemotherapy, radiation, and pembrolizumab maintenance against the standard treatment of chemotherapy, radiation, and pembrolizumab maintenance alone. The study aims to investigate whether this induction approach improves progression-free survival and overall survival, while assessing treatment toxicity and biomarker effects. Participants are randomly assigned to one of two groups. In the standard care group, patients receive weekly cisplatin and pembrolizumab every three weeks alongside daily radiation therapy for 5 weeks, followed by brachytherapy for 4 to 5 treatments, and then pembrolizumab maintenance every six weeks for up to 15 cycles. In the experimental group, patients first receive induction chemotherapy with carboplatin and paclitaxel weekly for 3 weeks, plus pembrolizumab every three weeks for 2 cycles, then receive the same chemoradiation and pembrolizumab maintenance schedule, with radiation delivered in weeks 7 to 13. Treatment is given unless disease progression or unacceptable side effects occur. Throughout the trial, participants undergo imaging scans including PET, CT, chest x-ray, and MRI, along with blood sample collection to monitor disease and biomarkers. After completing treatment, patients are followed every 3 months for 2 years, then every 6 months for up to 3 more years. Researchers measure progression-free survival as the primary outcome and assess overall survival, adverse events, treatment completion, biomarker levels, and radiation quality. Safety and treatment effects are closely monitored during the study period lasting several years.

Researchers are evaluating the use of lanreotide before surgery compared to surgery alone to prevent pancreatic fistulas in patients with pancreatic cancer or pancreatic lesions that might become cancerous. This phase III trial aims to see if lanreotide, a drug similar to the bodys hormone somatostatin and used in certain tumors, can reduce complications like pancreatic fistulas after distal pancreatectomy surgery. Participants are randomly assigned to receive either lanreotide or a saline placebo by a quick injection under the skin within 36 hours before their planned distal pancreatectomy. Blood samples will be taken before surgery and on the first and third days after surgery, with possible collection of pancreatic fluid on these days as well. After surgery, patients will be followed up at 4, 8, and 12 months. During the study, researchers will assess the occurrence of pancreatic fistulas within 60 days after surgery, hospital stay length, and quality of life changes using specific questionnaires. They will also monitor other postoperative complications and the time to start any additional chemotherapy. Blood, pancreatic fluid, and tissue samples will be collected for future research, with all participants monitored carefully throughout the study period.

Researchers are studying patients with stage II primary invasive cutaneous melanoma to compare the effects of two different surgical excision margins 1cm versus 2cm. The goal is to determine if narrower margins are as safe as wider margins in preventing melanoma recurrence and if they can improve patients quality of life. This trial also looks at the impact of these excision sizes on health services and society. Participants will be randomly assigned to receive either a 1cm or 2cm wide local excision margin around the primary melanoma lesion. Both groups will undergo sentinel lymph node biopsy and may have reconstruction surgery if needed. The surgery must be done within 120 days of diagnosis and within 28 days of randomization. During the study, participants will be followed for up to 60 months to measure disease-free survival as the primary outcome. Additional assessments include local recurrence, distant disease-free survival, melanoma-specific and overall survival, quality of life questionnaires, neuropathic pain evaluations, adverse event monitoring, and health economic analysis. Follow-up questionnaires and safety checks will occur at multiple time points up to 24 months after surgery, with longer-term monitoring continuing up to 120 months.

Researchers are investigating treatments for small cell lung cancer that has spread to the brain, focusing on whether stereotactic radiosurgery SRS is better at preserving memory and thinking abilities compared to whole brain radiation therapy that avoids the hippocampus HA-WBRT combined with the drug memantine. This phase III trial evaluates cognitive function, symptom burden, survival outcomes, and side effects in patients receiving these treatments. The study also explores brain imaging biomarkers and the economic impact of therapies. Participants are randomly assigned to one of two groups. One group receives stereotactic radiosurgery, which delivers a high dose of radiation directly to brain tumors over one or several days. The other group receives hippocampal-avoidant whole brain radiation daily for two weeks along with memantine taken orally once or twice daily for up to 24 weeks. Both groups undergo blood sample collection and magnetic resonance imaging MRI throughout the study period. During the study, participants complete neurocognitive tests measuring memory and thinking skills, as well as patient-reported questionnaires about cognitive difficulties and symptoms. After treatment, follow-up visits occur every 2 to 3 months for one year and then every six months thereafter to monitor disease progression, survival, adverse events, and other outcomes. The main measurement focuses on the time until neurocognitive failure, assessed up to one year after treatment.

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.