Elizabeth

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to the standard treatment of chemotherapy with or without radiation improves survival for patients aged 5 to 60 with early stage classical Hodgkin lymphoma. This phase III trial compares progression-free survival and overall survival between the standard therapy and the immunotherapy-enhanced approach, as well as patient-reported outcomes and long-term side effects. Participants initially receive two cycles of ABVD chemotherapy every 28 days and then undergo imaging to classify their early response. Based on risk level and response, patients are assigned to one of eight treatment arms that include either continuing standard chemotherapy, receiving immunotherapy drugs, or combinations with involved-site radiation therapy. Treatments are delivered intravenously or orally in cycles lasting 28 days. Imaging and blood samples are collected throughout the trial. Participants are monitored regularly with PET scans, CT or MRI imaging, and blood tests. Follow-up visits occur every 3 months in the first year, then every 6 months for years two and three, and annually up to 12 years from registration. Researchers assess survival outcomes, adverse events, patient-reported symptoms and quality of life, and metabolic tumor burden. Long-term effects such as cardiovascular and pulmonary health are also evaluated using questionnaires and clinical assessments.

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.

Researchers are evaluating a new schedule of alternating cycles of chemoimmunotherapy chemotherapy plus pembrolizumab and immunotherapy pembrolizumab alone as the first treatment for patients with advanced lung or head and neck cancers. This phase II study aims to see if less frequent chemotherapy during the induction phase can effectively control the cancer while preserving quality of life. The trial also monitors safety and response rates over time. The study has three groups based on cancer type. Each group receives alternating cycles combination chemoimmunotherapy cycles consisting of drugs like carboplatin, paclitaxel, pemetrexed, or 5-fluorouracil with pembrolizumab, followed by cycles of pembrolizumab alone. The number of cycles varies by group, with up to four or six cycles during induction. After induction, maintenance therapy with pembrolizumab alone or combined with pemetrexed continues for up to two years. Participants will have regular assessments including imaging and laboratory tests before and during treatment to measure tumor response and monitor side effects. Researchers will track how many patients complete the induction therapy cycles and evaluate overall response rates at 6 weeks. Safety is monitored throughout the study, which can last up to three years for progression and adverse event follow-up. Patients will provide informed consent and be closely monitored during the trial.

Researchers are evaluating how to best recommend chemotherapy for patients with Stage IIB, IIC, or Stage III colon cancer based on the presence or absence of circulating tumor DNA ctDNA after surgery. This Phase IIIII trial explores whether ctDNA status can help guide decisions about the need for adjuvant chemotherapy and identify the optimal chemotherapy regimen for those at high risk of recurrence. Circulating tumor DNA is a promising biomarker that may detect microscopic residual cancer cells that traditional methods might miss. Participants are assigned to groups based on their ctDNA results after surgery. Those without detectable ctDNA ctDNA- may undergo serial monitoring without treatment or receive different chemotherapy regimens such as mFOLFOX6 or CAPOX for 3 to 6 months. Patients with detectable ctDNA ctDNA who have a higher risk of recurrence are randomized to receive either standard chemotherapy regimens like mFOLFOX6 or CAPOX for 6 months or a more intensive regimen called mFOLFIRINOX for 6 months. Central ctDNA testing is performed using the Signatera test to guide these assignments. During the study, participants have blood samples collected for ctDNA testing and undergo imaging scans to check for cancer recurrence. Researchers assess disease-free survival, overall survival, and chemotherapy compliance over several years. The study includes monitoring for safety and treatment effects, with follow-up planned for up to 5 years after randomization. Participants health status, laboratory tests, and tumor markers are regularly evaluated throughout the treatment and follow-up periods.

This research aims to evaluate the safety and effectiveness of adjusting fluoropyrimidine FP chemotherapy doses based on genetic testing for DPYD variants in cancer patients. The study focuses on patients with cancers such as colorectal, breast, head and neck, and gastrointestinal neoplasms. It compares the occurrence of severe FP-related toxicities in patients with one DPYD gene variant receiving reduced doses against patients with normal DPYD genes receiving standard doses. This prospective treatment study seeks to validate DPYD-guided dosing strategies in a real-world clinical setting. Participants receive treatment in two groups the control arm receives 100% of standard FP doses according to the BEACON order plan, with dose reductions applied if severe toxicities occur. The experimental arm includes patients with one DPYD variant who start with 50% of the regular FP dose for the first two cycles, with possible dose escalation if tolerated. The chemotherapy drugs studied include Fluorouracil injection and Xeloda Capecitabine. Throughout the study, participants are monitored for severe fluoropyrimidine-related toxicities Grade 3 to 5 over a period of up to 24 months. Researchers will also track patterns of dose modifications, such as reductions or escalations. The study involves genetic testing before therapy, regular assessments of treatment response and safety, and follow-up to measure outcomes related to toxicity and treatment adjustments.

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 comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are investigating neoadjuvant therapy optimization for patients with stage II-III HER2-positive early-stage breast cancer. This phase 2 open-label study uses a novel molecular phosphoprotein-based biomarker assay called HER2 Activation Response Predictive Signature HARPS to identify HARPS-positive and HARPS-negative tumors. The study aims to assess the pathologic complete response rate, 3-year invasive disease-free survival, correlation of circulating tumor DNA ctDNA changes with outcomes, and quality of life changes in patients undergoing adaptive treatment based on HARPS status. Participants with HARPS-positive tumors will receive trastuzumab and pertuzumab for three cycles. Treatment response will be monitored by ctDNA and breast MRI. If responsive, they continue dual HER2-targeted therapy for at least eight cycles before surgery. Non-responders receive added chemotherapy docetaxel, paclitaxel, or Abraxane alongside trastuzumab and pertuzumab before surgery. Patients with HARPS-negative tumors and detectable ctDNA start with a combination of taxane, platinum, trastuzumab, and pertuzumab. If ctDNA clears, they continue the same treatment before surgery if not, therapy escalates to anthracycline-based regimens or trastuzumab deruxtecan as per physician choice. Participants undergo tumor testing for HARPS status and ctDNA collection before treatment. They receive breast MRIs and ctDNA monitoring throughout therapy. Researchers will evaluate treatment-emergent adverse events up to 36 months, invasive disease-free survival over three years, and quality of life measures. The total enrollment is 50 patients, with 25 in each HARPS cohort. The study includes regular visits for treatment administration, monitoring, and surgery, with long-term follow-up to assess outcomes and safety.

Researchers are evaluating whether simply observing patients after surgery is as effective as continuing pembrolizumab treatment in preventing cancer recurrence in people with early-stage triple-negative breast cancer TNBC who had a complete response after receiving chemotherapy plus pembrolizumab before surgery. This Phase III trial aims to determine if stopping pembrolizumab post-surgery can maintain recurrence-free survival while potentially improving quality of life and reducing treatment burden. Participants are randomly assigned to one of two groups after finishing chemotherapy with pembrolizumab and surgery. One group continues pembrolizumab intravenously every 3 or 6 weeks for 27 weeks. The other group undergoes observation without further pembrolizumab for the same period. Throughout the study, patients have tumor biopsies and blood collected, along with imaging such as mammography, breast ultrasound, or MRI during follow-up. Participants will be monitored for recurrence-free survival and overall survival for up to 10 years. The study also assesses adverse events, quality of life, financial impact, and work productivity at about 27 weeks after starting the assigned treatment or observation. Safety and treatment effects are tracked through biopsies, imaging, blood tests, and patient questionnaires during the study and follow-up.

Researchers are evaluating a combination treatment involving TAS-102 with oxaliplatin alternating with TAS-102 and irinotecan, along with bevacizumab, for late-stage metastatic colorectal cancer mCRC that has progressed after standard therapies. This phase II trial aims to assess the disease control rate and time to progression using this sequential approach. Participants will take TAS-102 orally twice daily on days 1 to 5 of each 14-day treatment cycle. Oxaliplatin infusion is given on day one of one cycle, alternating with irinotecan infusion on day one of the next cycle. Bevacizumab is also given alongside these treatments. Treatment continues until disease progression is seen on scans or adverse effects require stopping. During the study, participants will have regular assessments including scans to monitor disease progression. Researchers will measure outcomes like disease control rate, progression-free survival, overall survival, response rate, and response duration for up to 100 months. Safety and treatment tolerability will be closely monitored, and participants will be evaluated regularly to track their health and response to therapy.