Bath

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to standard chemotherapy, with or without radiation, can improve survival for patients aged 5 to 60 years with newly diagnosed stage I or II classical Hodgkin lymphoma. This phase III trial compares outcomes in groups based on their early response to initial chemotherapy, aiming to understand if immunotherapy can lead to better progression-free survival and overall survival compared to standard treatment alone. The study also looks at side effects, quality of life, and long-term health impacts across different patient groups. Participants first receive two cycles of standard ABVD chemotherapy every 28 days, followed by imaging to classify their response as rapid or slow early responders and their risk status as favorable or unfavorable. Based on these factors, patients are assigned to one of eight treatment arms that include either continued standard chemotherapy regimens or immunotherapy with brentuximab vedotin and nivolumab, sometimes combined with involved-site radiation therapy. Treatments are given intravenously or orally depending on the drugs, and cycles typically last 28 days. Imaging and blood samples are collected regularly throughout the study. Throughout the trial, participants undergo frequent scans such as FDG-PET, CT, MRI, and PET-CT to monitor their disease status. Blood samples and questionnaires assess treatment effects and quality of life. After completing treatment, patients have scheduled follow-up visits every 3 months for the first year, then every 6 months for two years, and annually up to 12 years to track long-term outcomes, side effects, and survival. The main measurements focus on progression-free survival, overall survival, treatment-related adverse events, and patient-reported experiences.

Researchers are evaluating whether high-dose gabapentin can prevent the need for opioid pain medication during chemoradiation therapy in patients with squamous cell carcinoma of the head and neck. Oral mucositis, a common side effect of radiation, causes severe pain and complications that often require opioid treatment, which has many side effects. This phase III trial aims to see if gabapentin can reduce opioid use and improve pain management in this patient group. Participants are randomly assigned to receive either gabapentin or a placebo starting with radiation treatment day 8. The dosing increases from once daily on day 1 to three times daily from day 3 onward. Both groups also receive standard chemotherapy, radiation, and pain medications as needed. Treatment continues until oral mucositis symptoms lessen and opioid use stops, followed by a gradual dose reduction over 11 days. Blood samples are collected throughout the study. Patients are followed up at 4 weeks, 3 months, and 6 months after completing chemoradiation therapy. Researchers measure the need for opioid use during treatment, time to first opioid use, patient-reported pain scores, quality of life, symptom outcomes, adverse events, tolerance to gabapentin, body mass index, lab results, feeding tube use, and opioid dosing. This comprehensive approach helps assess the effectiveness and safety of gabapentin in preventing opioid use for oral mucositis pain.

Researchers are evaluating a phase III trial comparing two treatment approaches for women with locally advanced cervical cancer that has spread to nearby tissues or lymph nodes. The study aims to see if adding induction chemotherapy with carboplatin, paclitaxel, and pembrolizumab before standard chemotherapy, radiation, and pembrolizumab maintenance can improve progression-free survival. This trial also investigates overall survival, treatment toxicity, treatment timing, and the role of biomarkers in predicting outcomes. Participants are randomly assigned to one of two groups. One group receives standard chemoradiation with cisplatin and pembrolizumab followed by pembrolizumab maintenance. The other group receives induction therapy with carboplatin, paclitaxel, and pembrolizumab, followed by chemoradiation with cisplatin and pembrolizumab, and then pembrolizumab maintenance. Radiation therapy includes external beam radiation and brachytherapy, given over several weeks. Treatments continue unless the cancer progresses or unacceptable side effects occur. Throughout the study, participants undergo various scans such as PET, CT, chest x-rays, and MRI, along with blood sample collections. After completing treatment, participants are followed every 3 months for 2 years, then every 6 months for 3 years to monitor cancer progression or survival. The primary outcome measured is progression-free survival up to 7 years. Additional assessments include treatment safety, biomarker studies, and radiation quality reviews.

Researchers are evaluating how well radiation therapy works compared to observation in patients with newly diagnosed grade II meningioma that has been completely removed by surgery. This phase III trial aims to determine the clinical benefit of adding radiotherapy after gross total resection of the tumor, while also assessing overall survival, disease-specific survival, side effects, cognitive function, patient-reported outcomes, and biomarker validation. Participants are randomly placed into one of two groups: the first group undergoes observation with regular MRI scans and blood collections, while the second group receives intensity-modulated radiation therapy or proton beam radiation therapy five days a week for about 6.5 to 7 weeks. Treatment continues up to a total of 33 radiation sessions unless the disease progresses or unacceptable side effects occur. Both groups are monitored with imaging and blood samples throughout the study. After treatment, participants are followed up at 3, 6, and 12 months, then every six months for the second and third years, and yearly up to 10 years. Researchers measure progression-free survival from randomization until disease progression or death. The study also collects tissue and specimen samples for future research and monitors patients for side effects and quality of life over the long term.

This research aims to compare the effects of usual care including regional radiation therapy with no regional radiation therapy in women with low-risk breast cancer. It focuses on patients with node positive breast cancer or T3N0 disease who typically receive endocrine therapy and possibly chemotherapy to prevent cancer recurrence. The study examines whether skipping regional radiotherapy still effectively prevents breast cancer from returning, potentially reducing unnecessary treatment and side effects. Participants will be divided into two groups: one receiving radiotherapy to the breast/chest area and surrounding lymph nodes, and the other receiving no regional radiotherapy. The study evaluates standard treatments, ensuring radiation therapy starts within specific time frames after surgery or chemotherapy. Treatments include breast-conserving surgery or mastectomy, along with endocrine therapy planned for at least five years. During the study, researchers will monitor breast cancer recurrence-free intervals over approximately 9.5 years. Participants will undergo regular assessments to track cancer status, side effects, and overall health. The study includes quality of life questionnaires for some patients and requires ongoing follow-up to document treatment effects, adverse events, and long-term outcomes.

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 investigating how well standard systemic therapy alone or combined with definitive treatment (prostate removal surgery or radiation therapy) works in men with prostate cancer that has spread to other parts of the body. This phase III trial aims to compare overall survival and other outcomes such as progression-free survival and quality of life between these treatment approaches. The study also explores differences in urinary function, pain, and physical functioning reported by patients over time. Participants begin with an induction period of 22 to 28 weeks receiving one of six forms of standard systemic therapy, which may include hormonal treatments, chemotherapy with docetaxel, or other approved medications. After this period, they are randomly assigned to either continue standard systemic therapy alone or receive standard systemic therapy plus definitive treatment of the primary tumor through prostatectomy within 8 weeks or radiation therapy within 4 weeks. The treatments are given according to accepted schedules, such as subcutaneous or intramuscular injections, oral medications, or intravenous infusions. During the study, participants undergo various assessments including physical exams, lab tests for prostate-specific antigen and testosterone levels, imaging scans, and patient-reported quality of life questionnaires. Researchers follow participants for up to 8 years to measure overall survival and monitor disease progression, symptoms, and side effects. Tissue and blood samples may be collected for future research. The study also tracks urinary and physical function changes and pain levels at multiple time points after starting therapy.

Researchers are evaluating whether increasing the dose of radiation therapy improves survival in patients with locally advanced pancreatic ductal adenocarcinoma who cannot have surgery and have already received 4 to 6 months of chemotherapy. This phase III trial compares higher-dose radiation therapy with usual care options, including additional chemotherapy, observation, or standard lower-dose radiation. The goal is to see if the higher radiation dose can better delay tumor growth and extend survival. Participants are randomly assigned to one of two groups. The standard care group may continue chemotherapy with regimens like FOLFIRINOX, NALIRIFOX, or gemcitabine/nab-paclitaxel for a total of 6 months or more, receive standard radiation therapy with concurrent chemotherapy, or be observed if they have completed chemotherapy. The other group receives dose-escalated radiation therapy delivered either over 5 fractions or 25 fractions, sometimes with concurrent chemotherapy. After radiation, patients who have not completed 6 months of chemotherapy are encouraged to finish it. Both groups may have blood samples taken, tumor biopsies, and imaging scans such as CT, MRI, or PET/CT. Participants are monitored every 3 months for 2 years and then yearly for up to 3 more years. Researchers collect data on overall survival, local tumor progression, progression-free survival, chemotherapy-free intervals, side effects, and quality of life using questionnaires. Biospecimens are also collected for future research. The study assesses whether higher-dose radiation therapy can improve survival and quality of life compared to standard treatments.

Researchers are evaluating two radiation therapy approaches for men with high-risk prostate cancer in this phase III trial. The study compares stereotactic body radiation therapy (SBRT), which delivers five higher-dose treatments over two weeks, to the usual radiation therapy that involves 20 to 45 treatments over 4 to 9 weeks. This trial aims to see if the shorter SBRT treatment can prevent cancer from returning as effectively as the longer conventional treatment while monitoring survival without metastasis. Participants are randomly assigned to one of two groups. One group receives SBRT with five treatments over two weeks, while the other undergoes external beam radiation therapy (EBRT) with 20 to 45 treatments over 4 to 9 weeks. Both groups have imaging scans such as bone scans, CT, MRI, or PET/CT during screening and study follow-up. Blood and urine samples may be collected optionally. Treatment continues as long as there is no disease progression or unacceptable side effects. During the study, participants have regular follow-ups every six months for five years. Researchers assess outcomes including metastasis-free survival, toxicity reported by physicians, patient-reported urinary and bowel function, fatigue, failure-free survival, overall survival, sexual function, quality of life, and treatment burden. Various questionnaires and imaging tests support these evaluations, helping to monitor safety and effectiveness over time.

Researchers are evaluating the effectiveness of adding radiation therapy to the usual immune therapy treatment with atezolizumab in people with extensive stage small cell lung cancer that has spread beyond the lungs. This phase II/III trial aims to compare progression-free survival and overall survival between patients receiving atezolizumab alone and those receiving atezolizumab combined with radiation therapy. The study also examines treatment side effects, the effect of radiation on tumor size and number, and the relationship between tumor burden before treatment and patient outcomes. Participants are randomly assigned to one of two groups. One group receives atezolizumab through an intravenous infusion every 21 days. The other group receives the same atezolizumab treatment plus radiation therapy once daily for five days each week over five weeks. During the study, patients undergo various imaging scans including PET/CT, CT, and MRI to monitor their cancer. Blood and tissue samples are also collected. After finishing treatment, patients are followed every three months for two years, then every six months for three years, and annually thereafter. Throughout the trial, researchers assess how long patients live without their cancer worsening and overall survival up to six years after starting treatment. They monitor the safety and side effects of the treatments, using imaging to evaluate tumor response. The study involves regular health exams, scans, and laboratory tests to carefully track each patient's progress and reactions to the therapies over time.