Pella

Researchers are investigating whether adding the drug Docetaxel to the usual hormone treatments, Androgen Deprivation Therapy ADT and Androgen-Receptor Pathway Inhibitor ARPI, can better control metastatic castration sensitive prostate cancer in men who have not responded optimally to initial hormone therapy. This phase III, international, open-label, randomized trial seeks to compare the effectiveness of this combined approach against the standard hormone therapy alone. Participants will be randomly assigned to receive either the standard hormone therapy with ADT plus ARPI or the same hormone therapy combined with Docetaxel chemotherapy. The trial focuses on men with metastatic prostate cancer who continue to have elevated PSA levels after 6 to 12 months of hormone-targeting treatment. Treatments are administered according to physician choice and assignment, and the study evaluates outcomes over a long period. During the trial, participants will be closely monitored with assessments including PSA levels and clinical progression over 39 months. Researchers will measure overall survival as the primary outcome, along with secondary outcomes such as PSA progression, PSA response, PSA kinetics, and progression-free survival. Participants must be accessible for treatment and follow-up to allow for complete documentation of treatment effects and adverse events throughout the study duration.

Researchers are evaluating two digital mindfulness-based interventions to improve mental health and well-being in younger breast cancer survivors who have elevated depressive symptoms. This phase III randomized trial focuses on women diagnosed at or before age 50, who completed primary cancer treatments at least six months earlier. The study aims to compare the effectiveness of live instructor-led sessions via Zoom and a self-paced app-based program, exploring which approach best supports psychological health in this population. Participants will be assigned to one of three groups the live online mindfulness sessions MAPs LO conducted weekly for 6 weeks via Zoom, the MAPs App delivering the same content in shorter sessions over 6 weeks, or a meditation-only control group accessing guided audio meditations. Both English and Spanish speakers can participate in the live online and meditation groups, while the app is only available in English. Tablets and internet hotspots are provided if needed. All groups have access to the UCLA MARC mindfulness meditation app throughout the 6-month follow-up. During the study, participants will attend weekly sessions for the live group or engage with app content at home, with usage tracked to measure intervention dose. Researchers will assess depressive symptoms shortly after the intervention and again up to 6 months later, along with fatigue symptoms. They will also investigate factors influencing intervention effects, such as baseline distress and social determinants, and evaluate the cost-effectiveness of the programs. The total study duration includes a 6-week intervention period plus follow-up assessments out to 6 months.

Researchers are evaluating an online educational program called Current Together After Cancer CTAC to see if it helps colorectal cancer survivors who had surgery receive follow-up care that matches current guidelines. This phase III trial focuses on patients with stage II or III colorectal cancer who have had their tumors surgically removed. The study aims to improve patients knowledge about surveillance, their confidence in managing follow-up care, and satisfaction with the involvement of a supporter in their care. Patients in the trial are randomly assigned to one of two groups. One group and their supporter get access to the CTAC intervention website, which contains educational content and interactive modules related to colorectal cancer surveillance. The other group and their supporter receive access to a general health education website. Participants may review their assigned website as often as they like for up to 16 months. During the study, participants will complete questionnaires at baseline, 3 months, and 16 months to assess knowledge, self-efficacy, cancer worry, preferences, and satisfaction with supporter engagement. Researchers will measure whether patients receive colorectal cancer surveillance aligned with guidelines at 16 months. The study also explores how supporters participation relates to patient outcomes. Participants may be contacted via email or phone for study activities and are encouraged to complete all scheduled assessments.

Researchers are comparing two chemotherapy combinations for treating advanced, unresectable, or metastatic HER2 negative adenocarcinomas of the esophagus, gastroesophageal junction, and stomach. This phase III trial evaluates modified FOLFIRINOX fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan with or without nivolumab versus modified FOLFOX fluorouracil, leucovorin calcium, and oxaliplatin with or without nivolumab. Chemotherapy drugs act to stop tumor growth by killing cells or stopping division, and immunotherapy with nivolumab may affect the immune system to hinder tumor growth and spread. Participants are randomized into two groups one receives mFOLFIRINOX plus nivolumab as clinically indicated, and the other receives mFOLFOX plus nivolumab as clinically indicated. Treatments are administered intravenously. Throughout the study, participants undergo magnetic resonance imaging MRI, computed tomography CT scans, and may provide blood samples. Nivolumab is given as needed based on clinical assessment during the trial. Participants will be monitored up to 2 years from randomization for overall survival, with secondary measures including progression-free survival, response rates, duration of response, adverse events, and patient-reported outcomes collected at baseline and during treatment cycles. Safety and tolerability are evaluated, and exploratory analyses include biomarker assessments such as PD-L1 combined positive score and cell-free DNA. The trial includes regular imaging and clinical assessments to track disease status and treatment effects.

The Master Screening and Reassessment Protocol MSRP for the NCI MyeloMATCH clinical trials focuses on patients with myeloid cancers, including acute myeloid leukemia AML and myelodysplastic syndrome MDS. The study evaluates the use of a screening tool and specific laboratory tests, including rapid genetic testing of bone marrow and blood, to better identify biomarkers that can guide treatment decisions. The goal is to improve the ability to assign participants to targeted treatment studies or to continue standard care through a Tier Advancement Pathway TAP. Participants undergo bone marrow aspiration and blood collection for biomarker testing. Based on their mutational profiles, patients may be assigned to specific treatment substudies testing therapies tailored to their cancer or placed on TAP if no targeted treatment is available. The study includes various treatment regimens involving drugs such as azacitidine, venetoclax, daunorubicin, and others administered via intravenous, oral, or subcutaneous routes. Screening also includes echocardiography or multigated acquisition scans to assess heart function. Throughout the study, participants have ongoing bone marrow biopsies and aspirations, blood sample collections, and additional imaging such as chest x-rays, PET, or CT scans as needed. Researchers monitor treatment assignment timing, treatment responses, adverse events, minimal residual disease, and patient survival. The study aims to maintain access to investigational treatments and collect specimens for translational research. The total duration varies by treatment assignment and disease progression, with continuous monitoring throughout.

Researchers are evaluating whether adding targeted radiotherapy can reduce the chance of lung cancer growing or spreading compared to the usual drug combination treatment for metastatic non-small cell lung cancer NSCLC. This Phase 3 trial focuses on patients whose disease has worsened and explores if this new approach is better or worse than standard care. The study involves patients with stage IV NSCLC without actionable driver mutations, who have experienced limited progression on first-line immunotherapy or chemotherapy. Participants are randomly assigned to one of two groups one group receives stereotactic body radiotherapy SBRT followed by standard therapy, while the other group receives systemic therapy chosen by their doctor without SBRT. SBRT must be started within 3 weeks of enrollment for those in the radiotherapy group. Treatments follow current NSCLC guidelines and consider prior therapies and patient safety, including assessments by radiation oncologists. During the study, participants undergo regular evaluations including imaging to monitor tumor progression, safety assessments, and quality of life questionnaires. Researchers will measure progression-free survival and overall survival over 5.5 years, alongside tracking adverse events and patient-reported outcomes. Participants must be able to complete questionnaires in English, French, or Spanish and remain available for treatment and follow-up throughout the study duration.

This trial evaluates whether a shorter duration of HER2-targeted therapy is as effective as the standard length for treating early-stage HER2-positive breast cancer in patients who had a complete response after preoperative chemotherapy with trastuzumab. The study focuses on comparing 6 months versus 12 months of combined neoadjuvant and adjuvant HER2 blockade and also assesses quality of life and safety outcomes. The trial aims to determine if shorter treatment can maintain similar recurrence-free survival and reduce side effects. Participants are randomly assigned to receive trastuzumab and possibly pertuzumab either intravenously or subcutaneously every 21 days. One group receives treatment for up to 17 cycles about 12 months, while the other group receives treatment for up to 9 cycles about 6 months, as long as no disease progression or unacceptable toxicity occurs. Throughout the trial, patients undergo heart function tests echocardiography or MUGA and breast imaging mammography, ultrasound, or MRI. Optional blood and tissue samples may be collected for additional studies. Participants are followed for recurrence and survival for up to 10 years after treatment begins, with check-ins every 6 months for the first 5 years and then yearly afterward. The study measures recurrence-free survival, overall survival, local and distant cancer recurrence, and patient-reported quality of life using specific questionnaires. It also monitors serious side effects and symptoms like diarrhea, fatigue, and rash. This comprehensive follow-up helps evaluate long-term outcomes and treatment impact.

Researchers are evaluating treatments for patients with differentiated thyroid cancer that does not respond to prior therapy and has a specific BRAF V600E mutation. This phase III trial compares the effects of cabozantinib versus a combination of dabrafenib and trametinib. Cabozantinib works by blocking enzymes involved in tumor growth, while dabrafenib and trametinib target proteins that regulate cell growth and tumor proliferation. The study aims to determine which treatment is safer and more effective for this type of thyroid cancer. Participants are randomly assigned to one of two groups. One group receives dabrafenib twice daily and trametinib once daily in 28-day cycles, while the other group receives cabozantinib once daily in similar 28-day cycles. Treatment continues unless the disease progresses or unacceptable side effects occur. Throughout the study, patients undergo CT scans, blood sample collections, and may have MRI scans. After treatment ends, participants are followed every 3 months for 2 years and then every 6 months for up to 5 years. During the trial, participants will be monitored with imaging tests and laboratory evaluations to assess tumor progression and treatment effects. Questionnaires will also be used to evaluate quality of life and tolerability. Researchers will measure progression-free survival, response rates, overall survival, duration of response, and safety. The study includes ongoing assessments of adverse events at specified intervals. Participants will be followed long-term to monitor outcomes related to their thyroid cancer and treatment.

This trial studies patients with newly diagnosed grade 3 astrocytoma that have mutations in the IDH1 or IDH2 genes. It evaluates whether adding the enzyme inhibitor vorasidenib to the usual chemotherapy drug temozolomide after radiation can improve outcomes compared to temozolomide with a placebo. This phase III study focuses on progression-free survival and other measures of treatment effectiveness and safety in these patients. Participants receive radiation therapy using advanced techniques such as intensity-modulated radiation therapy, volume modulated arc therapy, pencil beam scanning, or intensity-modulated proton therapy once daily Monday through Friday for 33 sessions. Starting four weeks after radiation, patients are randomly assigned to receive temozolomide with either vorasidenib or placebo taken orally in 28-day cycles, with temozolomide given on days 1-5 and the study drug or placebo on days 1-28, for up to 12 months. Blood samples and MRI scans are collected throughout the treatment period. After completing study treatment, participants will be followed regularly for up to 10 years to monitor progression-free survival and overall survival. Follow-ups occur every three months for the first two years, every four months for the next two years, and then every six months thereafter. Researchers also assess response rates, safety, quality of life, seizure control, and other health outcomes during treatment and follow-up to better understand the impact of vorasidenib combined with temozolomide.

Researchers are evaluating a digital chatbot-enabled intervention compared to standard remote genetic services in adolescents and young adult AYA cancer patients. The study aims to increase the uptake of genetic counseling and testing for cancer predisposition syndromes, which can guide enhanced screening and risk reduction to lower cancer morbidity and mortality. Despite its importance, many AYAs do not currently receive recommended genetic counseling and testing, and this research explores if digital tools can improve access and outcomes. Participants are randomly assigned to one of two groups. One group receives standard care involving telehealth visits with a genetic counselor for pretest education and result disclosure, along with standard genetic testing. The other group uses the Genetic Journey Chatbot for digital pretest education, with an option to request telehealth counseling as needed they also undergo standard genetic testing and receive counselor result disclosure. The chatbot supports patients by answering questions, identifying barriers, and sending reminders during the testing period. A third group includes non-patient participants who complete interviews. During the study, participants complete surveys and interviews at baseline and follow-up visits at 6 and 12 months. Researchers measure uptake of genetic counseling and testing within six months, along with secondary outcomes such as knowledge, distress, satisfaction, communication with relatives, healthcare behaviors, counselor time, and costs over up to 42 months. The study assesses short-term and long-term cognitive, emotional, and behavioral effects, as well as implementation factors. Participant safety and engagement are monitored throughout.