Ravenna

Researchers are evaluating treatments for patients with BRAF-V600 mutant melanoma that has spread to the brain. This phase II trial compares two combinations encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The study aims to determine which approach is more effective at shrinking and controlling brain metastases, and it also examines survival, response rates, and treatment safety. Patients are randomly assigned to one of two treatment groups. One group takes encorafenib daily by mouth, binimetinib twice daily by mouth, and receives nivolumab through an intravenous IV infusion every 28 days. The other group receives nivolumab IV every cycle and ipilimumab IV over 30 minutes during the first four cycles, with cycles repeating every 21 days initially, then every 28 days. Treatment continues unless disease worsens or side effects become unacceptable. Participants undergo brain MRI scans before enrollment and throughout the study to assess tumor response using specific criteria. After completing treatment, patients are followed every six months for two years, then yearly up to three years. The study collects tissue, blood, spinal fluid, and stool samples for future research. Researchers monitor progression-free survival as the main outcome, along with overall survival, response rates, and treatment side effects.

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.

Researchers are comparing two types of radiation therapy, proton beam radiation therapy PBT and intensity modulated photon radiotherapy IMRT, to treat patients with stage I to IVA esophageal cancer. The study aims to find out whether PBT improves overall survival and causes fewer serious heart and lung side effects compared to IMRT. Additional goals include examining symptom burden, quality of life, tumor response, cost-effectiveness, hospitalization length, lymphocyte levels, and rates of treatment failures and complications. Participants are randomly assigned to one of two groups. One group receives PBT over 28 treatment sessions, five days a week for 5.5 weeks, combined with chemotherapy chosen by the patient and their doctor. The other group receives IMRT on the same schedule with similar chemotherapy options. After chemoradiation, patients may have surgery to remove the esophagus tumor if they are eligible. Throughout the study, blood samples and imaging scans PETCT or CT are collected. Participants are closely monitored during treatment and followed for up to eight years. Follow-up visits occur every 3 to 6 months for the first three years and annually thereafter. The study measures overall survival, heart and lung side effects, symptom changes, tumor response, hospitalization time, immune cell counts, and quality-adjusted life years. The study also collects biospecimens for future research on treatment complications and assesses economic factors related to each radiation therapy.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII 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 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 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.

Researchers are evaluating whether adding stereotactic ablative radiotherapy SABR to standard immunotherapy improves outcomes in patients with metastatic or unresectable renal cell carcinoma that cannot be surgically removed. This phase II trial compares SABR combined with immunotherapy against immunotherapy alone. The study focuses on nephrectomy and radiographic progression-free survival as primary measures and also assesses safety, response rates, overall survival, and other outcomes over up to 8 years. Participants are randomly assigned to one of two treatment groups. One group receives standard immunotherapy regimens, including combinations of drugs such as nivolumab, ipilimumab, pembrolizumab, avelumab, axitinib, cabozantinib, or lenvatinib administered intravenously or orally at specified intervals. The other group receives SABR on three days over 1 to 3 weeks plus the same immunotherapy options. Imaging scans such as CT or MRI, and sometimes bone scans and blood collections, are done throughout the trial. Participants undergo regular assessments including imaging and blood tests to monitor the cancers response and safety of treatments. After treatment completion, follow-up visits occur every 6 months for 5 years, then annually for 3 more years, totaling up to 8 years of monitoring. Researchers measure outcomes such as progression-free survival, response rates, nephrectomy rates, and adverse events during this time to evaluate the treatments.