Clinical Research Directory

Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease

Background: Spinal metastatic disease constitute a serious clinical problem in oncology. Bones are the third most common organ where metastases are located, and the spine is the place where they are most often located. Due to the complexity of the clinical problem, metastatic spine disease remains of interest to many medical specialties: neurosurgery, orthopedics, clinical oncology, radiotherapy and rehabilitation. With the development of modern diagnostic methods and wider access to them, the demand for neurosurgical treatment in this group of patients is growing. Surgical treatment is undertaken in cases of spinal cord compression, instability, spinal deformation or pain that is resistant to radiotherapy. The standard treatment in most cases is posterior instrumentation of the spine using titanium pedicle screws. Unfortunately, these systems cause numerous artifacts in diagnostic imaging, both in CT and MRI. These distortions make it difficult to plan radiotherapy and determine the optimal dose that would avoid healthy tissues. Moreover, artifacts could make difficult postoperative follow-ups aimed at assessing local recurrence. The solution to these problems is the use of radiolucent implants. There are systems based on carbon fibers embedded in PEEK which do not cause typical artifacts for titanium implants. Study plan: The open, three-arm, prospective randomized study is planned to involve 226 patients with metastatic disease of the spine, with a known or undiagnosed primary site. Patients will be qualified for 2 types of interventions. The first one includes treatment with stereotactic radiotherapy (SBRT) in the first stage of treatment and early instrumentation of the spine with titanium implants. The second type of intervention includes patients qualified for surgical treatment using spine stabilization and postoperative SBRT. Patients within this arm will be randomized into two groups differing in the type of material the instrumentation is made of: carbon-PEEK or titanium. The study group will be patients stabilized with carbon implants, and the control group will be those who will have titanium implants. Study population: The study includes adult patients with metastatic spine disease, with a known or unknown primary tumor, qualified for SBRT and surgical treatment. Assumed effects: It is assumed that the treatment proposed in the project would extend progression free survival by several months or achieve local control in an additional 5% of patients. Moreover, by improving the quality of imaging, earlier diagnosis of local recurrences and implementation of appropriate locoregional treatment would be possible.

To Determine Whether it is Feasible to Treat Patients Requiring Urgent Radiotherapy Diagnosed With Metastatic Cord Compression (MSCC) on the Magnetic Resonance Linear Accelerator (MRL) in a Single Appointment and Compare it to the Standard of Care Radiotherapy Pathway

The goal of this clinical trial is to understand whether the Magnetic Resonance Linear Accelerator (MRL) could expedite Radiotherapy treatment for Metastatic Cord Compression (MSCC) by removing the need for a planning CT (pCT) scan prior to treatment. Radiotherapy will be delivered in one appointment on the MRL and compared to the standard of care of two appointments: a CT scan and a Radiotherapy appointment. The main questions it aims to answer are: * Can the MRL deliver successful treatment of MSCC in a single 1-hour appointment? * Can the MRL treat participants within 24 hours from the doctor's decision to treat? * Did it take less time from consent to completion of treatment when patients were treated on the MRL? * Do the questionnaire scores reflect satisfaction with treatment on the MRL? Researchers will compare treatment on the MRL in one appointment to a group receiving standard of care radiotherapy in two appointments. Participants in both groups will receive the same prescription of 8Gray (Gy) in one treatment (fraction) delivered with one posterior-anterior beam as per our department policies and national standards. Participants will be asked to complete an optional questionnaire prior to treatment to monitor the diversity of the study population. This questionnaire is anonymised, no personal data that could identify a participant is collected on this questionnaire. After treatment participants will be asked to complete an experience questionnaire, to assess treatment experience. Once the questionnaire is complete active participation in the trial is no longer needed, researchers will monitor participants notes for up to 12 months after treatment to record participant well being and function.

Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression.

Metastatic spinal cord compression (MSCC) is a serious complication to metastatic cancer and when diagnosed life expectancy is short. Treatment is palliative radiotherapy (RT). Early esophageal toxicity is underreported but can seriously impact quality of life (QoL). The aim of the ESO-SPARE trial is to investigate if esophagus sparing RT can decrease patient reported esophageal toxicity without compromising ambulatory function or increase other toxicities. 200 patients with MSCC in the thoracic or cervical spine referred for RT will be randomized to either standard or esophagus/pharynx sparing RT. Subsequently participants will be followed with PROM (Patient Reported Outcome Measures) for 9 weeks. PROM-CTCAE questionnaires on upper GI toxicity and pain will be collected daily for 5 weeks and weekly for 4 weeks. Questionnaires evaluating QoL and physical function will be collected weekly for 9 weeks.