Brachytherapy

This trial evaluates the safety and effectiveness of intratumoral Alpha DaRT-224, a device delivering diffusing alpha-emitter radiation, in treating immunocompromised patients with cutaneous squamous cell carcinoma SCC. The study aims to measure the objective response rate ORR using RECIST v1.1 criteria and track progression-free survival PFS, overall survival OS, and local tumor control up to 12 months after treatment. It is a multicenter, single-arm, open-label clinical study involving up to 28 participants. Participants will receive DaRT seeds, which are encapsulated Radium-224 radioactive sources inserted directly into the SCC tumor. These sources emit short-lived alpha particles locally in the tumor microenvironment. The seeds remain implanted for 14 to 21 days before removal. The treatment targets tumors up to 7 cm in size with single lesions that can be fully covered by the radiation sources. The study does not include a comparison group. During the study, participants will undergo multiple CT scans and blood tests to monitor tumor response and safety. Researchers will assess the best overall tumor response starting from the time of DaRT seed removal. Adverse events related to the device will be classified and recorded according to established criteria. Patients must provide informed consent and will be followed for up to 12 months after seed insertion to evaluate survival and tumor control outcomes.

Researchers are evaluating the safety and effectiveness of combining radioactive particles with the drug fluzoparib to treat advanced, inoperable soft tissue sarcoma. This phase II clinical trial focuses on patients with measurable tumors that cannot be surgically removed, aiming to understand how well this combination works in controlling the disease. Participants receive implantation of radioactive iodine-125 seeds followed by oral doses of fluzoparib at 150 mg twice daily after meals, starting 48 hours after the implantation. Fluzoparib is given continuously for 2 months per cycle, with tumor assessments monthly during the first cycle. Depending on tumor response, additional particle implantations up to three may be given, with medication pauses before surgeries and continuation after surgery until 6 months after the last implantation. The maximum treatment duration with fluzoparib is one year. Throughout the study, patients undergo regular tumor evaluations using CT or MRI scans and monitoring for side effects. Key outcomes include the objective response rate after 12 months, progression-free survival at multiple time points, overall survival rates, and safety events. Patients who experience intolerable side effects, disease progression, or choose to stop treatment enter a survival follow-up phase. The total participation may extend until study completion in December 2028.

Researchers are studying the long-term effects of high dose rate HDR brachytherapy in men who have isolated local relapses of prostate cancer after undergoing radical prostatectomy. The study aims to find out if HDR brachytherapy improves control rates and reduces complications compared to conventional external irradiation. This observational study focuses on men with prostate cancer recurrence visible on imaging and suitable for HDR brachytherapy. The treatment involves HDR brachytherapy combined with external beam radiation and six months of androgen deprivation therapy. HDR brachytherapy targets small, well-defined tumor areas using imaging techniques like PETMRI and transrectal ultrasound guidance to deliver higher radiation doses while sparing sensitive surrounding tissues. This approach aims to reduce radiation exposure to critical structures such as the external urinary sphincter and penile bulb. Participants will receive HDR brachytherapy as part of their usual medical care and will be monitored for biochemical relapse-free survival over five years. The study includes regular imaging assessments, PSA monitoring, and evaluation of treatment effects and complications. The total participation period covers long-term follow-up to observe outcomes and safety in men treated for isolated prostate bed relapses after prostatectomy.

Researchers are investigating whether a higher radiation dose to the tumor can increase the rate of preserving the rectum in patients with non-locally advanced rectal cancer. This prospective study focuses on patients who want to avoid surgery and aims to improve quality of life by reducing long-term side effects. The trial explores a new radiation approach using cone-beam computed tomography CBCT for more accessible and adaptive treatment compared to MRI-guided methods. The study involves adding a simultaneous integrated boost SIB to the standard chemoradiotherapy regimen. Patients receive 25 radiation sessions where the mesorectum gets 2.0 Gy per fraction and the tumor plus affected lymph nodes receive 2.4 Gy per fraction. This single-arm trial includes 25 patients and uses CBCT imaging daily to guide treatment and monitor tumor and organ movement. Participants will have five MRI scans during treatment weeks, complete questionnaires at five time points, and provide blood samples to assess treatment effects and safety. Researchers will track organ preservation rates over two years, clinical and pathological responses, survival outcomes, bowel function, quality of life, and any treatment-related toxicities. The total follow-up lasts up to three years for some outcomes, with regular assessments to understand the effectiveness and impact of this adapted radiation therapy.

Researchers are studying the safety and effectiveness of two different radiotherapy methods in women with high-risk breast cancer who have had a total mastectomy followed by immediate implant-based breast reconstruction. This phase 3 trial compares hypofractionated radiotherapy HFRT with conventional fractionated radiotherapy CFRT to evaluate their impact on reconstruction outcomes and cancer control. The study has two treatment groups one receives HFRT delivering 43.5 Gy in 15 fractions over 3 weeks, and the other receives CFRT delivering 50 Gy in 25 fractions over 5 weeks. Both treatments are given after surgery and chemotherapy as appropriate. The trial monitors participants for reconstruction failure and other implant-related adverse events as primary and secondary outcomes. Participants will undergo regular assessments including physical exams, cosmetic evaluations, and quality of life questionnaires at baseline and multiple time points up to five years. Researchers will monitor implant complications, radiation side effects, disease-free survival, and overall survival. The total duration of participation may extend to several years to capture long-term outcomes and safety.

This research aims to collect data during High Dose Rate HDR brachytherapy treatments to track the brachytherapy source inside patients. The goal is to verify that the treatment plan is being delivered accurately and to detect errors or motion that are not currently monitored. The study involves patients receiving HDR brachytherapy for gynecologic endometriumcervix or prostate cancer, treated on a CT couch. An external imaging panel the investigational product will be positioned beside the treatment table to continuously acquire data throughout the treatment. This device will not touch the patient or change the clinical workflow, as it is placed at a safe distance and powered by two cables integrated neatly with the treatment table setup. The data collected will be compared against the planned treatment information to identify discrepancies and improve treatment verification. Participants will undergo their usual HDR brachytherapy treatment while the external panel collects data automatically during radiation exposure. Clinical staff will not need to perform additional actions. The data analysis will be done offline after treatment sessions to avoid interruptions. The primary outcomes measured are dwell times and dwell positions during treatment within one year. The total participation duration depends on the patients treatment schedule.

Researchers are evaluating Micro-Ultrasound Guided Focal Laser Ablation MicroUSgFLA as a treatment for men with intermediate-risk prostate cancer. This study aims to determine if this minimally invasive procedure can safely delay or avoid the need for more invasive treatments like surgery or radiation. The research focuses on men diagnosed with intermediate-risk prostate cancer to explore a simpler alternative to current options. Participants will receive MicroUSgFLA treatment using the TRANBERGCLS Thermal Therapy device, which targets cancerous areas in the prostate guided by micro-ultrasound imaging. This single-arm study involves treating patients and then assessing them through MRI scans, biopsies, and PSA blood tests at six months after treatment. The procedure is designed to be less complex than MRI-guided treatments and may be accessible in community settings. During the study, participants will complete questionnaires about urinary and erectile function before treatment. Follow-up assessments include monitoring PSA levels, imaging, and biopsies to evaluate the treatments technical success and impact on prostate cancer. The studys main outcomes are measured over six months, with safety and effectiveness closely monitored by the research team.

This research aims to evaluate the use of MRI guided Focal Laser Ablation MRgFLA in men with early stage, low to intermediate risk prostate cancer. The study focuses on determining how well MRgFLA can control prostate cancer while reducing the need for more invasive treatments like surgery or radiation. Previous studies suggest that MRgFLA may be a safe option with minimal side effects and help many patients avoid radical therapies over several years. Participants will receive focal laser ablation treatment guided by MRI, targeting the visible tumor with a margin around it to ensure thorough treatment. This is a single arm study where all patients will undergo the MRgFLA procedure using The TRANBERGCLSThermal Therapy device. After treatment, patients will have follow-up MRI scans and prostate biopsies at 6 months and 2 years, along with regular PSA blood tests to monitor cancer status. During the study, researchers will assess the presence of clinically significant prostate cancer using MRI and biopsy results. Patients will also complete validated questionnaires measuring urinary and sexual function before and at several points after treatment to track quality of life changes. The total monitoring period includes evaluations at 6 months, 12 months, and 24 months after treatment, allowing detailed assessment of treatment effects and safety over time.

The trial investigates the effects of adding postoperative radiotherapy PORT to surgery for patients with Stage II or III thoracic esophageal squamous cell carcinoma who have already received neoadjuvant chemoradiotherapy nCRT. This study aims to compare overall survival time between patients treated with surgery plus PORT and those treated with surgery alone. Recurrence is a major challenge in treating this cancer, and the study evaluates whether PORT can reduce recurrence and improve survival. Patients are randomly assigned to two groups to assess these outcomes with a follow-up of at least 60 months. Participants in Group A receive a combination of neoadjuvant radiotherapy and chemotherapy, followed by esophagectomy surgery and then postoperative radiotherapy using intensity modulated radiotherapy IMRT to deliver a total dose of 18 Gy in 10 fractions. Group B receives the same neoadjuvant radiotherapy and chemotherapy plus esophagectomy but without the postoperative radiotherapy. The neoadjuvant radiotherapy involves 45 Gy in 25 fractions delivered 5 days per week, with chemotherapy given as two cycles of Docetaxel and Cisplatin every 21 days. Surgery is performed 4-6 weeks after chemotherapy. During the study, participants undergo assessments for overall survival as the primary outcome, with secondary outcomes including disease-free survival, local recurrence rate, and side effects monitored up to 12 weeks after treatment. The trial includes detailed evaluations of treatment effects over a minimum of five years post-treatment. Participants provide informed consent and are monitored for safety and treatment response throughout the study period.

Researchers are investigating the best way to intensify radiotherapy for patients with prostate cancer that has spread to pelvic lymph nodes but not to distant sites. This trial focuses on patients confirmed by PSMA PETCT imaging to have node-positive prostate cancer without distant metastases. The study seeks to determine if increasing the radiation dose to the prostate, the pelvic lymph nodes, or both improves long-term outcomes, including preventing the spread of cancer and enhancing survival. Participants receive a standardized ultrahypofractionated whole-pelvis radiotherapy regimen delivered in five treatments, combined with long-term androgen deprivation therapy, with optional androgen receptor pathway inhibitors. The trial uses a 2 x 2 factorial design to compare four groups prostate radiotherapy without additional boost with intermediate or higher nodal radiation doses, and prostate radiotherapy with an additional ablative prostate boost using high-dose-rate brachytherapy, low-dose-rate brachytherapy, or single-fraction SBRT boost combined with either intermediate or higher nodal doses. The boost technique is assigned based on availability and suitability per participant. Throughout the study, participants undergo clinical assessments, PSA and testosterone monitoring, toxicity reporting, and patient-reported quality of life evaluations focused on urinary, bowel, sexual, and global health domains. Imaging with PSMA PET is used at baseline and upon suspected progression to assess disease status. The main outcome measured is metastasis-free survival over up to 10 years, with additional outcomes including overall survival, progression-free survival, local and nodal control, time to castration-resistant cancer, treatment side effects, and quality of life. The study includes long-term follow-up to capture late events and treatment effects.