Radiation Therapy

Researchers are evaluating new imaging techniques to better detect tumors in people with brain metastasis. This study focuses on comparing positron emission tomography (PET) combined with magnetic resonance imaging (MRI) against other imaging methods to determine if these newer techniques can more accurately identify cancerous tissue. Improved imaging is important to help locate tumors and guide future cancer treatments. Participants will undergo a single PET/MRI scan using a radiotracer called F-Fluciclovine, followed by a separate MRI scan with a tracer. These imaging methods are performed on the same machine that creates detailed pictures using magnets and radio waves. The PET and MRI scans assess protein levels in tumor tissue, with higher protein levels suggesting tumor presence rather than normal brain tissue. During the study visit, which lasts about three hours, participants will be asked to lie still for 30 to 60 minutes during imaging. Researchers will measure amino acid uptake into tumor tissue to compare imaging results. Patients must be able to complete the scans without requiring intravenous sedation, and medication use for mild anxiety is allowed under specific conditions. All scans and procedures are conducted to monitor tumor presence and treatment changes safely.

Researchers are studying a new treatment approach for patients with surgically removable head and neck squamous cell carcinoma (HNSCC), a common and serious type of cancer in the head and neck region. The study evaluates the safety and tolerability of combining immune-targeted therapy with a lysogenic herpes simplex virus (HSV) as a neoadjuvant treatment to reduce tumor size before surgery. This innovative combination aims to improve surgery outcomes and lower the chances of cancer returning or spreading. Participants receive a combination of treatments including Tislelizumab given on days 1 and 22, and continuous daily Afatinib from days 1 to 42. They also receive injections of the lysogenic HSV virus directly into lymph nodes, with dosing based on lymph node size, given twice two weeks apart. After these treatments, patients undergo standard surgical removal of the tumor. The HSV virus injection includes an initial dose-escalation phase followed by a dose-expansion phase to find the most effective dose. During the study, patients are closely monitored for side effects and treatment tolerance, including checking for dose-limiting toxicities during surgery. Researchers will assess how well the tumor responds to treatment by examining major and complete pathological responses and overall tumor shrinkage up to eight weeks after treatment. They will also monitor adverse events for up to 12 weeks and follow disease-free survival for one year. The study duration and procedures are planned to provide detailed information on the safety and effects of this combined therapy.

Researchers are evaluating the safety and effectiveness of a new neoadjuvant treatment combining Cadonilimab, a PD-1/CTLA-4 bispecific antibody, with platinum-based chemotherapy (Paclitaxel Polymeric Micelles for Injection and Cisplatin) for patients with locally advanced esophageal squamous cell carcinoma. This Phase 2 clinical trial aims to measure pathologic complete remission rates after 2 to 4 treatment cycles, alongside other measures like objective remission rate, major pathologic remission rate, surgical removal rate, and 2-year survival outcomes. Participants receive Cadonilimab intravenously at 10 mg/kg on day 3 every 3 weeks, combined with Paclitaxel Polymeric Micelles administered intravenously (230 mg/m2 for cycle 1; possibly increased to 260 mg/m2 for cycles 2-4 depending on blood counts and side effects) and Cisplatin intravenously at 25 mg/m2 daily for 3 days every 3 weeks. Treatment lasts approximately 12 weeks, covering 2 to 4 cycles before surgery. Throughout the study, participants undergo regular assessments including pathological evaluation after surgery to determine remission, as well as monitoring of overall and progression-free survival over 2 years. Safety and organ function are closely observed, with eligibility requiring adequate heart, liver, kidney, and blood function. Participants are followed from treatment initiation through surgery and beyond to evaluate clinical outcomes and side effects.

Researchers are investigating treatments for locally advanced rectal cancer in this national, multicenter, randomized, placebo-controlled Phase III clinical trial. The study aims to evaluate whether combining immunotherapy with total neoadjuvant therapy (TNT) offers better benefits than long-course radiotherapy followed by TNT alone. It also compares the effectiveness and side effects of different radiotherapy types when combined with immunotherapy under TNT. Participants are assigned to one of three groups: one receives short-course radiotherapy (SCRT) followed by immunotherapy and chemotherapy; another receives long-course radiotherapy (LCRT) with concurrent chemotherapy plus immunotherapy and chemotherapy; and the third group receives LCRT with concurrent chemotherapy followed by TNT chemotherapy and a placebo instead of immunotherapy. Immunotherapy or placebo is given via intravenous infusion every three weeks for six cycles. After neoadjuvant therapy, patients may undergo surgery or opt for a watch-and-wait approach if they achieve complete remission. During the study, participants undergo dynamic monitoring including MRI and blood tests to track tumor response and minimal residual disease, especially for tumors close to the anal verge. Researchers assess outcomes such as event-free survival over three years, complete response rates, overall survival, and treatment side effects using standardized criteria. The trial includes follow-up visits and safety evaluations over several years to monitor long-term effects and treatment results.

Researchers are evaluating a combination of immune-targeted therapy and lysogenic herpes simplex virus (HSV) virotherapy as a neoadjuvant treatment for patients with surgically resectable head and neck squamous cell carcinoma (HNSCC). This study aims to improve surgical success and reduce the risk of recurrence and metastasis by using these therapies before surgery. The trial is a prospective, single-arm study focused on the safety and tolerability of this innovative approach for patients with locally advanced HNSCC without distant metastasis. Participants will receive tislelizumab on days 1 and 22, afatinib daily from days 1 to 42, and injections of lysogenic HSV virus into lymph nodes in two doses spaced two weeks apart. The virus dose will be adjusted based on lymph node size, with a dose-escalation phase followed by a dose-expansion phase using the most effective dose. After these treatments, patients will undergo standard surgery to remove the tumor. During the study, researchers will monitor participants for dose-limiting toxicities during surgery and evaluate responses such as major pathologic response and complete pathologic response. Additional assessments include adverse events up to 12 weeks, objective response rate up to 8 weeks, and one-year disease-free survival. Participants will attend scheduled visits for treatment administration, surgery, and follow-up to assess safety and treatment effects throughout the trial period.

Researchers are evaluating a decisional support intervention called the University of Rochester-Geriatric Oncology assessment for Acute Myeloid Leukemia (UR-GOAL) in older adults newly diagnosed with acute myeloid leukemia (AML). This randomized controlled trial compares the UR-GOAL intervention to an attention control to see if it improves patient distress, shared decision making, and decisional conflict. The study involves four sites and includes patients aged 60 years and older with a new AML diagnosis who have not yet started cancer-directed treatment. Participants are randomly assigned to one of two groups. In the UR-GOAL intervention arm, patients and their caregivers view an AML educational video, complete a best-worst scaling exercise to identify their priorities, and receive a summary report to review and discuss with healthcare providers during clinic visits. Oncologists receive a report including the patient's geriatric assessment, priorities, and prognosis perception to guide discussions. In the attention control arm, patients and caregivers watch a nutritional video, complete a nutrition questionnaire, and receive related handouts to review. Oncologists receive the completed nutrition questionnaire for review. During the study, participants will complete several assessments including the Distress Thermometer Questionnaire at one month, the Shared Decision Making Questionnaire and Decisional Conflict Scale at two weeks, and observed shared decision making at the start. Researchers will monitor patient distress, decision-making quality, and patient-caregiver-oncologist communication. The study is expected to last through June 2030, with patients and caregivers engaging in educational and assessment activities alongside their usual clinical care.

Brain metastasis is a serious condition with limited survival for untreated patients, typically only 1-2 months. Researchers are studying isotoxic high dose fractionated stereotactic radiation therapy (iHD-SRT) as a local treatment to improve tumor control while protecting brain function. This trial explores optimizing stereotactic radiotherapy (SRT) dosage based on normal tissue tolerance to enhance treatment effects for brain metastases, addressing the lack of prospective data comparing different SRT dosages and fractionation schemes. Participants will receive iHD-SRT, a precise radiation therapy using high-resolution equipment to deliver individualized doses with biologically effective dose (BED10) greater than 50 Gy but less than 100 Gy. This approach aims to maximize tumor control while respecting organ-at-risk limits to reduce brain toxicity. The study is a single-arm, open-label, prospective trial enrolling 35 patients over two years, followed by one year of monitoring. During the study, participants will undergo treatment with iHD-SRT and be closely monitored for treatment completion and side effects, especially radiation-induced brain necrosis within one year. The main outcomes measured are the proportion of patients receiving the targeted radiation dose and the incidence of brain necrosis. Follow-up will assess safety and feasibility, with an expected total involvement of three years from treatment start to final evaluation.

This research aims to explore how patients and their families experience and express hope during cancer treatment in phase 1 or phase 2 clinical trials, especially for pediatric and young adult patients with relapsed, refractory, or non-curable cancers. The study focuses on understanding how hope changes over time and how healthcare providers perceive hope and goal alignment in this context. The goal is to support families better by identifying key themes and areas for improvement in hope-related care. The study is observational and uses photo-narrative interviews where participants share photos representing their hope and discuss their feelings about it. These interviews occur at enrollment and follow-up timepoints, either in-person or virtually. Clinicians will also be interviewed to gain their perspectives on patient and family hope. Additionally, focus groups involving patients, caregivers, and clinicians will help co-design a supportive care intervention based on these findings. Demographic and clinical data will be collected from medical records. Participants will engage in several interviews at enrollment, 3, 6, 9, and 12 months, sharing photos and reflections. Researchers will review electronic medical records at these times to gather clinical context. Focus groups will be held after at least 12 months to develop supportive care strategies. This process includes ongoing assessments of hope experiences from multiple perspectives, aiming to create meaningful support for families facing challenging cancer treatments.

Researchers are investigating a new way to predict severe oropharyngeal mucositis caused by radiation therapy in patients with nasopharyngeal carcinoma (NPC), a cancer common in southern China. The study focuses on a mucosal contouring method based on swallowing-induced breakthrough pain, which showed better prediction results than previous methods. This prospective, multicenter, observational study aims to further evaluate the effectiveness of this new predictive approach. The study observes patients with NPC who are undergoing radical radiotherapy or chemoradiotherapy. Researchers will use the new mucosal delineation method to assess radiation-induced oropharyngeal mucositis by monitoring swallowing-induced breakthrough pain. This method aims to identify patients at high risk for severe mucositis to help guide timely interventions, although no specific treatments are provided within the study. Participants will be monitored throughout the study period, which can last up to three years. Researchers will collect continuous records of mucositis severity and self-reported pain during swallowing. The study measures the accuracy of the predictive model using various statistical tools like AUC, sensitivity, and specificity. Safety and other important predictors of mucositis will also be evaluated, with no additional treatments or interventions required for participants.

Researchers are evaluating the safety, feasibility, and effectiveness of stereotactic body radiation therapy (SBRT) in treating centrally and ultra-centrally located lung tumors. The study involves patients with primary, oligo-metastatic, or oligo-progressive non-hematological cancers, focusing on tumor control, treatment-related side effects, quality of life, and survival outcomes. It aims to improve understanding and future treatment strategies for these challenging tumor locations. Patients with centrally located lung tumors receive SBRT using standard linear accelerators with daily cone beam CT image-guidance and plan adaptation, while those with ultra-centrally located tumors are treated on MR-linac machines with daily MR-guided plan adaptation. Central tumors are defined by proximity to specific airways and organs, and ultra-central tumors are even closer to critical structures. Tumor location and suitability are assessed by diagnostic imaging, and treatment plans are adapted daily to target tumors precisely. Participants will be monitored extensively, with treatment-related adverse events recorded from baseline through up to 10 years post-treatment at multiple intervals. Follow-up includes imaging scans and clinical assessments to measure tumor control, disease progression, and survival. Quality of life is also assessed. The study enrollment continues until target patient numbers are met, allowing detailed long-term evaluation of treatment outcomes and safety for both tumor groups.