Bath

Researchers are comparing two chemotherapy treatment plans for patients with newly diagnosed intermediate-risk rhabdomyosarcoma, a type of soft tissue cancer. This phase III trial evaluates whether a higher dose chemotherapy over a shorter time Regimen A is better than a lower dose chemotherapy followed by maintenance treatment over a longer time Regimen B, both combined with standard surgery and radiation. The study also aims to assess survival rates, treatment side effects, and molecular features of the tumor. Participants are randomly assigned to one of two treatment groups. Regimen A involves multiple cycles of vincristine, dactinomycin, and cyclophosphamide given intravenously every 21 days, with possible surgery during week 12 and radiation treatments during specified cycles. Regimen B includes alternating cycles of vincristine, dactinomycin, cyclophosphamide, and irinotecan, followed by 24 weeks of maintenance chemotherapy with vinorelbine and oral cyclophosphamide. Both groups undergo imaging scans and biopsies as needed during treatment. Throughout the study, participants will have regular CT or MRI scans and blood tests, along with other procedures such as lymph node biopsies, bone marrow tests, and lumbar punctures to monitor disease status. After treatment, follow-up visits occur every 3 months for the first year, then less frequently up to 5 years to check for event-free survival and overall health. The trial also collects biospecimens for future research and evaluates treatment effects on fertility and quality of life.

Researchers are evaluating the effect of adding intensity-modulated post-operative radiation therapy I-PORT to standard chemotherapy or immunotherapy in patients with non-small cell lung cancer NSCLC who still have lymph node cancer after surgery. This phase II trial aims to see if I-PORT improves disease-free survival and whether it increases serious heart or lung side effects compared to standard care alone. The study also looks at overall survival, cancer control, and patient-reported symptoms related to heart and lung health. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy or immunotherapy alone, continuing treatment if the cancer does not progress or side effects are manageable. The other group receives I-PORT once daily Monday through Friday for 5 to 6 weeks, starting 4 to 12 weeks after surgery, followed by the same standard chemotherapy or immunotherapy. Imaging scans and blood samples are collected during treatment in both groups. After completing treatment, participants are followed for five years with check-ups every three months for two years, then every six months for three years. During these visits, researchers assess disease recurrence, survival, side effects, and patient symptoms. The study uses various scans including CT, MRI, and FDG-PET, along with blood tests, to monitor participants health and treatment impact over time.

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 high-dose gabapentin can reduce the need for opioid pain medications in patients experiencing mouth sores oral mucositis caused by chemotherapy and radiation treatment for squamous cell carcinoma of the head and neck. Oral mucositis can cause severe pain and complications such as difficulty swallowing, weight loss, feeding tube placement, interruptions in cancer treatment, hospitalizations, and decreased quality of life. Opioids are commonly used to treat this pain but come with significant side effects and risks of long-term use. In this phase III trial, patients are randomly assigned to receive either gabapentin or a placebo starting at radiation treatment day 8. The medication is given orally once daily on day 1, twice daily on day 2, and three times daily from day 3 onward. Both groups also receive standard chemotherapy, radiation, and pain management. Treatment continues until symptoms improve and other pain medications are stopped, followed by a gradual reduction in the study drug dose. Blood samples are collected throughout the study. After treatment, patients are followed for up to 6 months. Participants will have their need for opioids monitored during chemoradiation, along with the time to first opioid use and pain scores assessed up to 4 weeks after treatment ends. Researchers will also explore opioid use duration, symptom and quality of life changes, adverse events, medication tolerance, body weight, kidney function, immune cell counts, and feeding tube requirements. Study visits include regular assessments, blood tests, and questionnaires to gather detailed information on patient outcomes and safety.

Researchers are evaluating treatments for patients with high-risk, locally advanced cervical cancer that has spread to nearby tissue or lymph nodes. This Phase III trial compares adding induction chemotherapy with carboplatin, paclitaxel, and pembrolizumab before standard chemotherapy, radiation, and pembrolizumab maintenance against the standard treatment of chemotherapy, radiation, and pembrolizumab maintenance alone. The study aims to investigate whether this induction approach improves progression-free survival and overall survival, while assessing treatment toxicity and biomarker effects. Participants are randomly assigned to one of two groups. In the standard care group, patients receive weekly cisplatin and pembrolizumab every three weeks alongside daily radiation therapy for 5 weeks, followed by brachytherapy for 4 to 5 treatments, and then pembrolizumab maintenance every six weeks for up to 15 cycles. In the experimental group, patients first receive induction chemotherapy with carboplatin and paclitaxel weekly for 3 weeks, plus pembrolizumab every three weeks for 2 cycles, then receive the same chemoradiation and pembrolizumab maintenance schedule, with radiation delivered in weeks 7 to 13. Treatment is given unless disease progression or unacceptable side effects occur. Throughout the trial, participants undergo imaging scans including PET, CT, chest x-ray, and MRI, along with blood sample collection to monitor disease and biomarkers. After completing treatment, patients are followed every 3 months for 2 years, then every 6 months for up to 3 more years. Researchers measure progression-free survival as the primary outcome and assess overall survival, adverse events, treatment completion, biomarker levels, and radiation quality. Safety and treatment effects are closely monitored during the study period lasting several years.

Researchers are evaluating how well radiation therapy works compared with observation in patients who have a newly diagnosed grade II meningioma that has been completely removed by surgery. This phase III trial aims to determine the clinical benefit of adding radiation therapy after complete tumor removal and also studies overall survival, disease-specific survival, side effects, neurocognitive function, patient-reported outcomes, and biomarker correlations. Participants are randomly assigned to one of two groups. One group undergoes observation with regular MRI scans and blood collection throughout the study. The other group receives intensity-modulated radiation therapy IMRT or proton beam radiation therapy five days a week for about 6.5 to 7 weeks, totaling 33 treatment sessions, unless disease progression or unacceptable side effects occur. Both groups continue to have MRI scans and blood tests during the study. Participants are followed for up to 10 years after treatment or observation, with visits scheduled at 3, 6, and 12 months, then every 6 months for years 2 and 3, and yearly thereafter. The study measures time without disease progression as the main outcome, along with survival rates, adverse events, cognitive function changes, and adherence to treatment protocols. Tissue and blood samples are also collected for ongoing research.

Researchers are investigating how well standard systemic therapy, with or without additional definitive treatment such as prostate removal surgery or radiation therapy, works in treating men with prostate cancer that has spread to other parts of the body. This phase III trial aims to compare overall survival and progression outcomes between patients receiving systemic therapy alone and those receiving systemic therapy plus definitive treatment of the primary tumor. The study also examines quality of life factors, including urinary function, pain, and physical functioning. Participants first receive one of six acceptable forms of standard systemic therapy for 22 to 28 weeks, which may include hormonal therapies, oral medications, injections, or chemotherapy drugs like docetaxel. After this induction period, participants are randomly assigned to continue standard systemic therapy alone or to receive systemic therapy plus prostatectomy or radiation therapy within a specific timeframe. Following treatment, participants are monitored and followed up for up to eight years. During the study, participants undergo various assessments including physical exams, laboratory tests for prostate-specific antigen PSA and testosterone levels, and imaging scans to monitor disease progression. Patient-reported outcomes related to urinary symptoms, pain, and quality of life are collected at multiple time points up to three years. The main outcome measured is overall survival over an eight-year period. Researchers also bank tissue and blood samples for future studies and observe safety and disease progression throughout the follow-up period.

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 dose-escalated radiation therapy compared to usual care for patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have already completed 4 to 6 months of chemotherapy. The study is a phase III trial aiming to determine if higher doses of radiation can improve 3-year overall survival, as well as assess effects on tumor progression, chemotherapy-free intervals, treatment toxicity, and quality of life. This trial is led by NRG Oncology and focuses on patients without disease progression after initial chemotherapy. Participants are randomly assigned to one of two groups. The first group receives standard care, which may include additional chemotherapy options such as FOLFIRINOX, NALIRIFOX, or gemcitabinenab-paclitaxel, standard radiation therapy with concurrent chemotherapy, or observation. The second group receives dose-escalated radiation therapy delivered in either 5 or 25 fractions, with or without concurrent chemotherapy for the 25-fraction option. After radiation, patients who have not completed 6 months of chemotherapy are encouraged to finish it, with treatment beyond 6 months at the physicians discretion. Imaging and tissue biopsies are performed throughout the study. Participants undergo various assessments including blood sample collection, CT scans, MRI, and optional PETCT scans before and during treatment. Tumor tissue biopsies are also collected. Follow-up visits occur every 3 months for the first 2 years and annually for an additional 3 years. Researchers measure overall survival, local disease progression, progression-free survival, chemotherapy-free intervals, and adverse events. Quality of life is evaluated using specific questionnaires over the course of participation.

Researchers are comparing two radiation therapy approaches for men with high-risk prostate cancer to see if a shorter treatment duration can prevent cancer recurrence as effectively as the usual longer radiation schedule. This phase III trial evaluates stereotactic body radiation therapy SBRT, which delivers higher doses in five treatments over two weeks, against standard external beam radiation therapy EBRT, which involves 20 to 45 treatments over 4 to 9 weeks. The study includes men with specific high-risk features and uses advanced imaging to assess outcomes. Participants are randomly assigned to one of two groups. One group receives SBRT, involving five precise radiation treatments over two weeks, while the other group receives EBRT with 20 to 45 treatments over 4 to 9 weeks. Both groups undergo imaging tests such as bone scans, CT, MRI, or PETCT during screening and on study. Optional blood and urine samples may be collected during the trial. During the study, participants are followed every six months for up to five years to monitor metastasis-free survival, treatment effects on urinary, bowel, and sexual functions, fatigue, and overall quality of life. Various patient questionnaires and physician assessments track side effects and treatment burden. The trial also includes long-term evaluations of survival and disease progression, with imaging and laboratory tests supporting these assessments.