Furlong

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating the effectiveness of radiation therapy with or without the chemotherapy drug cisplatin in patients with stage III-IVA squamous cell carcinoma of the head and neck who have had surgery to remove their tumors. This phase II trial aims to understand if adding cisplatin to radiation therapy improves disease-free survival, especially considering the role of p53 mutations in the cancer cells. The study also investigates toxicities and potential genomic factors that might influence treatment outcomes. Patients are randomly assigned to one of two treatment groups. One group receives intensity-modulated radiation therapy (IMRT) alone once daily, five days a week for six weeks. The other group receives the same radiation treatment combined with weekly intravenous cisplatin over one to two hours, also for six weeks. Treatment continues as long as there is no disease progression or unacceptable side effects. During the study, participants undergo regular follow-ups every six months for three years and then yearly for seven more years to monitor for cancer recurrence or new tumors. Researchers assess disease-free survival, tracking the time from randomization until cancer returns, a second tumor develops, or death. Additional laboratory tests and biomarker analyses are performed to understand genetic changes and treatment effects. Safety and toxicities are closely monitored throughout the study period.

Researchers are evaluating the effectiveness of using brain magnetic resonance imaging (MRI) scans alone compared to combining MRI scans with prophylactic cranial irradiation (PCI) in treating patients with small cell lung cancer (SCLC). This phase III trial aims to determine if MRI surveillance alone is not worse than adding PCI in terms of overall survival. The study also looks at cognitive function, brain metastasis-free survival, and treatment side effects among patients with limited or extensive-stage SCLC. Participants are randomly assigned to one of two groups. One group receives PCI, which is radiation therapy focused on the brain, given over two weeks for 20 minutes per day, five days a week, along with scheduled MRI scans at 3, 6, 9, 12, 18, and 24 months. The other group undergoes MRI scans at the same intervals without receiving PCI. Both groups are monitored closely through these MRI scans to track any spread of cancer to the brain. During the study, patients will have regular MRI scans, cognitive assessments, and evaluations of side effects and survival outcomes up to two years after randomization. Blood samples will be collected for future research. Researchers will monitor overall survival, cognitive failure rates, and brain metastasis occurrence, aiming to understand if avoiding PCI might reduce side effects without compromising survival. Participant involvement includes multiple scheduled scans and tests over a two-year follow-up period.

Researchers are comparing two treatment approaches for patients with brain metastases: stereotactic radiosurgery (SRS) and hippocampal-avoidant whole brain radiotherapy (HA-WBRT) combined with the drug memantine. SRS is an outpatient procedure delivering a high dose of radiation to small brain areas in one or two days, while HA-WBRT aims to treat the whole brain but reduce radiation to the hippocampus, which is important for memory. Memantine is used alongside HA-WBRT to help relieve symptoms like memory problems caused by radiation. This phase III trial seeks to determine if SRS is better, the same, or worse than the usual treatment with whole brain radiation therapy (WBRT) alone, considering cancer control, life span, quality of life, and symptoms. The study compares two groups: one receiving SRS with a single dose of 18-22 Gy, and the other receiving HA-WBRT radiation at 30 Gy over 10 sessions plus memantine starting at 5 mg and increasing weekly up to 20 mg daily. Patients must have between 5 and 15 brain metastases, with no single tumor larger than 2.5 cm. The trial requires participating centers to have specific radiosurgery equipment and credentialing. Treatment must begin within 14 days after enrollment. Both approaches are closely monitored to assess their effects. Participants will undergo MRIs and neurocognitive testing to evaluate memory and brain function over 4.5 years. Researchers will track overall survival and neurocognitive progression-free survival as primary outcomes. Patients will complete quality-of-life questionnaires in English or French, and their kidney function will be tested before treatment. The study includes careful documentation of treatment effects, side effects, and follow-up visits to ensure thorough evaluation of both treatment options.

Researchers are evaluating treatments for men with prostate cancer that has returned after surgery, shown by rising PSA levels. The trial tests two main questions: whether adding enhanced systemic therapy (apalutamide combined with abiraterone and prednisone) to the standard care of prostate radiation and short-term hormone therapy helps patients without cancer spread beyond the pelvis, and whether adding targeted radiation to this enhanced therapy benefits patients whose cancer has spread outside the pelvis as seen on PET imaging. This phase III study aims to see if using PET scans to guide more personalized treatment improves outcomes compared to standard care alone. Participants are divided into four groups based on PET scan results. Those without cancer outside the pelvis receive either standard radiation plus hormone therapy or the same treatment with added apalutamide. Those with cancer spread beyond the pelvis receive similar treatments but may also get targeted radiation to the metastatic sites. Treatments include various forms of radiation therapy and hormone therapies given by injection or orally. The study includes baseline PET scans, possible repeat PET scans during follow-up, and treatment lasting about six months. During the study, participants have regular assessments, including PET/CT or PET/MR imaging, blood tests, and quality-of-life questionnaires over two years and longer for some measures. Researchers track progression-free survival for up to 10 years, quality of life up to 24 months, and other outcomes like overall survival, side effects, and cognitive function. Follow-up visits occur every 3 months for two years, then less frequently up to 10 years to monitor health and treatment effects.