Carlisle

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer based on the presence or absence of circulating tumor DNA (ctDNA) after surgery. This Phase II/III trial focuses on patients with Stage IIB, IIC, or Stage III colon adenocarcinoma who have undergone tumor removal. The study aims to use ctDNA status to better predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy. Participants will be assigned to different treatment groups based on their ctDNA status after surgery. Patients without detectable ctDNA will undergo serial ctDNA monitoring without immediate treatment or receive standard chemotherapy regimens such as mFOLFOX6 or CAPOX for varying durations. Patients with detectable ctDNA will receive either standard chemotherapy or intensified regimens like mFOLFIRINOX. Treatments involve intravenous and oral chemotherapy drugs given over several cycles spanning weeks to months. Throughout the study, participants will have ctDNA testing using the Signatera test and be monitored for disease-free survival, overall survival, and recurrence up to five years after randomization. Safety and treatment adherence will also be tracked. Regular imaging and laboratory tests will assess disease status and organ function. The study may include re-randomization for patients who develop positive ctDNA during monitoring. Total involvement may last several years with follow-up for long-term outcomes.

Researchers are evaluating combinations of targeted drugs in people with advanced non-small cell lung cancer that has spread and shows specific changes in the EGFR and MET genes. This phase II Lung-MAP trial focuses on patients whose cancer has progressed after treatment with osimertinib and aims to compare the effectiveness of combining capmatinib, osimertinib, and ramucirumab. The study also investigates safety, response rates, and survival outcomes while collecting biological samples for further analysis. Participants are randomly assigned to one of two groups. One group receives capmatinib and osimertinib as oral medications plus ramucirumab given intravenously, while the other group receives only capmatinib and osimertinib orally. During the trial, patients undergo regular CT or MRI scans and blood sample collections to monitor their disease and treatment effects. The study includes detailed assessments of tumor responses and side effects over time. Throughout the trial, participants will have scans and blood tests at scheduled intervals to assess disease progression and treatment impact. Researchers will monitor progression-free survival as the main outcome, along with response duration and toxicity. Blood samples are also collected to study circulating tumor DNA. The study continues up to three years, with ongoing safety and efficacy evaluations. Participants must meet specific health criteria and provide informed consent before joining.

This research evaluates sentinel lymph node (SLN) biopsy compared to standard elective neck dissection (END) surgery for early-stage oral cavity squamous cell carcinoma (cT1-2N0). It is a phase II/III trial seeking to determine if SLN biopsy leads to better neck and shoulder function and quality of life at 6 months, and if it is not less effective than END in disease-free survival. Additional goals include comparing survival, toxicity, failure patterns, and diagnostic accuracy between the two surgeries. Participants are randomly assigned to one of two groups. One group receives an imaging agent injection followed by planar imaging and SPECT/CT to identify lymph nodes before undergoing SLN biopsy. The other group undergoes standard END surgery. Both groups have imaging studies such as FDG PET/CT, CT, and chest x-rays at screening and during follow-up. The trial also assesses hospital stay length, operative morbidity, and collects biospecimens for future studies. Participants will be followed after surgery at 3 weeks, then every 3 months for the first year, every 4 months in the second year, every 6 months in the third year, and yearly afterwards. Assessments include patient-reported neck and shoulder function and quality of life questionnaires, imaging for disease monitoring, and recording of survival outcomes. The primary outcomes focus on patient function and disease-free survival, with follow-up lasting up to 11 years to monitor long-term results and safety.

Researchers are evaluating the effectiveness of two digital mindfulness-based interventions for younger breast cancer survivors who experience elevated depressive symptoms. This phase III clinical trial focuses on women diagnosed with breast cancer at age 50 or younger who have completed their primary cancer treatments at least six months prior. The study aims to identify which digital mindfulness approach best improves mental health and well-being, while exploring factors that influence intervention benefits and cost-effectiveness. The study includes three groups: one attends live, instructor-led mindfulness sessions via Zoom once a week for six weeks; another uses a self-paced mindfulness app with structured lessons and exercises over six weeks; and a control group accesses guided audio mindfulness meditations. Participants without digital devices or internet access will be provided with tablets and hotspots. Both English and Spanish speakers are included in live and audio meditation groups, while the app group includes English speakers only. All groups have access to the mindfulness app for up to six months. Participants will attend sessions or use digital tools over six weeks, with daily home practice encouraged. Researchers will assess depressive symptoms shortly after the intervention and up to six months later, along with fatigue symptoms. Use of mindfulness materials and session attendance will be tracked to measure engagement. The study also collects information on emotion regulation, demographic factors, and social determinants of health to understand how these influence outcomes. Participation lasts approximately six months, with ongoing access to mindfulness resources during follow-up.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase II/III trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions; instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are evaluating the effectiveness of radiation therapy with or without the chemotherapy drug cisplatin in treating patients who have stage III-IVA squamous cell carcinoma of the head and neck and have undergone surgery. This phase II trial aims to understand how well these treatments work, focusing on disease-free survival and the role of p53 gene mutations in predicting patient outcomes. The study also examines treatment side effects and explores genetic changes that could guide new therapies. Participants are randomly assigned to one of two treatment 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 combined with weekly intravenous cisplatin over 1-2 hours for six weeks. After treatment, patients will be followed up every six months for three years and then annually for seven more years to monitor their health status and disease progression. Throughout the study, participants undergo various assessments including surgical tissue analysis for p53 mutations, imaging tests to check for disease spread, and regular evaluations of treatment side effects. Researchers measure disease-free survival, tracking the time until cancer recurrence, new tumors in the head and neck region, or death for up to ten years. Safety is monitored closely during treatment, with adverse events recorded up to six weeks after therapy. The total participation duration can extend up to ten years due to long-term follow-up.

This research aims to compare the effects of regional radiotherapy versus no regional radiotherapy in women with low-risk breast cancer who are receiving usual care. The study focuses on women with node-positive or T3N0 breast cancer who have undergone breast-conserving surgery or mastectomy, to see if avoiding regional radiotherapy works as well at preventing the cancer from returning. Participants receive either whole breast irradiation with or without regional radiotherapy to lymph nodes after surgery, or no regional radiotherapy following mastectomy or breast-conserving surgery. The study involves random assignment to these treatment groups and evaluates the impact of adding or omitting regional radiotherapy as part of their care. During the study, researchers will monitor breast cancer recurrence-free interval over 9.5 years, along with other outcomes such as invasive disease-free survival, mortality, overall survival, and quality of life. Patient-reported outcomes, arm mobility, adverse events, and cost-effectiveness are also assessed. Treatment adherence, follow-up visits, and collection of tumor tissue and blood samples are part of the participant's involvement throughout the trial.

Researchers are evaluating whether brain MRI scans alone can effectively monitor small cell lung cancer compared to the combination of MRI scans with preventive brain radiation called prophylactic cranial irradiation (PCI). This phase III trial aims to see if using MRI surveillance alone can maintain overall survival and reduce side effects, potentially prolonging patients' lives. The study also looks at cognitive function, brain metastasis-free survival, and treatment toxicities. Participants are randomly assigned to one of two groups. One group receives PCI radiation therapy to the brain over two weeks along with scheduled MRI scans at 3, 6, 9, 12, 18, and 24 months. The other group only undergoes MRI scans at the same time points without PCI. Some patients in the PCI group may receive hippocampal avoidance radiation to spare cognitive function. During the study, participants undergo regular MRI scans and cognitive testing to track brain health and cancer spread. Researchers monitor survival rates, cognitive failure-free survival, brain metastases occurrence, and adverse events for up to two years after randomization. Blood samples may be collected for banking. The total follow-up includes multiple visits and assessments to evaluate the effects of MRI surveillance alone versus combined PCI and MRI monitoring.

Researchers are evaluating treatments for patients with high-risk stage III-IV head and neck squamous cell carcinoma, especially those negative for p16 in oropharyngeal cancer. This phase II/III trial compares the usual post-surgery treatment of radiation therapy with cisplatin chemotherapy against alternative combinations including docetaxel with cetuximab, and the addition of an immunotherapy drug called atezolizumab. The study aims to improve disease-free and overall survival while assessing side effects and quality of life. Participants are randomly assigned to one of three main treatment groups: radiation therapy with cisplatin weekly for six weeks; radiation with docetaxel plus cetuximab; or radiation with cisplatin plus atezolizumab given every three weeks for up to eight doses starting one week before radiation. Radiation is delivered using intensity-modulated radiation therapy (IMRT) daily, five days a week for six weeks. The docetaxel-only arm was closed after phase II. Blood samples are collected regularly, and imaging and biopsies may be performed as needed. During the study, participants undergo medical exams, blood tests, and imaging scans to monitor their response and safety. They are followed up closely after treatment completion at 1 and 3 months, then every 3 months for 2 years, every 6 months for 3 years, and annually thereafter. The primary outcomes measured include disease-free survival and overall survival up to seven years, along with assessments of symptom burden, quality of life, and treatment side effects throughout and after therapy.

Researchers are evaluating stereotactic radiosurgery (SRS) compared to whole brain radiotherapy that avoids the hippocampus (HA-WBRT) combined with memantine for treating small cell lung cancer that has spread to the brain. This phase III trial aims to determine if SRS, which targets tumors with a high dose of radiation in a single session, reduces cognitive decline and memory problems compared to the standard HA-WBRT plus memantine approach. The study also explores effects on brain disease progression, survival, symptom burden, and side effects in patients with brain metastases from small cell lung cancer. Participants are randomly assigned to one of two groups. One group receives SRS over one or several days, with blood samples and MRI scans collected during the study. The other group receives HA-WBRT once daily for two weeks along with memantine taken orally once or twice daily for up to 24 weeks, also with blood samples and MRI monitoring. Treatments continue unless there is disease progression or unacceptable side effects. After treatment, patients are followed every 2-3 months for one year, then every six months afterward. Throughout the study, participants undergo neurocognitive testing using a series of memory and thinking assessments, as well as patient surveys on cognitive difficulties and symptom burden. Researchers monitor brain scans, blood tests, and adverse events to compare outcomes between groups. The main measurement is the time until neurocognitive failure within one year, with additional follow-up on disease progression, survival, neurologic death, and treatment complications for up to ten years.