Clinical Research Directory

Intradurale Spinal Tumors: Management and Treatment

Intradurale spinal tumors are rare neoplastic lesions that involve the spinal cord and surrounding structures and may cause neurological symptoms such as pain, motor deficits, sensory disturbances, and sphincter dysfunction. Surgical resection is often the primary treatment when feasible and may improve neurological outcomes and relieve spinal cord compression. This retrospective observational study aims to analyze the epidemiological and clinical characteristics of patients who underwent surgical treatment for intradural spinal tumors at the Neurosurgery Unit of Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria between 2022 and 2024. Clinical, radiological, and pathological data will be collected from electronic medical records, operative reports, and diagnostic imaging. The study will evaluate preoperative and postoperative neurological status using the McCormick functional scale, as well as postoperative complications and tumor recurrence. The results of this study may contribute to improving the understanding of the clinical management of intradural spinal tumors and identifying factors associated with surgical outcomes and patient prognosis.

Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)

The goal of this clinical research study is to find out if stereotactic spine radiotherapy is safe and effective in the treatment of metastatic spine tumors. The feasibility of this type of treatment will be studied as will any side effects related to the treatment. The precision and accuracy of the CT-on-rails will also be studied.

Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms

The goal of this clinical trial is to learn if a higher dose of Stereotactic Spine Radiosurgery (SSRS), an advanced radiation technique, is better for treating cancer that has spread to the spine (spinal metastases). The study will also learn about the safety of using a higher dose. The main questions it aims to answer are: Does a higher radiation dose lead to fewer treatment failures (meaning the tumor growing back or causing serious side effects) one year after treatment? What are the side effects associated with the high dose compared to the standard dose? How does each radiation dose affect a patient's pain and quality of life? Researchers will randomly assign participants (like a coin toss) to one of two groups to compare the outcomes: The Standard Dose Group: Will receive a single radiation treatment of 16 Gy. The High Dose Group: Will receive a single, more powerful radiation treatment of 20 Gy. Participants in this study will: Receive a single, one-time, highly-focused radiation treatment (SSRS) to the spinal tumor. Attend regular follow-up visits at the clinic for checkups and imaging scans (like MRI). Complete questionnaires about their pain levels and quality of life during these visits.

Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases

This is a non-inferiority, randomised controlled trial to investigate the effect of stereotactic ablative body radiotherapy (SABR) compared to separation surgery followed by SABR in ambulatory patients with malignant epidural spinal cord compression (MESCC). The primary objective of the project is investigating the effect of SABR compared to separation surgery followed by SABR in ambulatory patients with MESCC on retaining ambulatory function. The primary endpoint of the study is ambulatory function 3 months post treatment defined as: being able to walk 10m without aid; being able to walk 10m with aid (cane, rollator, one persons help, …); not being able to walk. Secondary outcomes are local control, progression free survival, early and late adverse effects, quality of life, effect on pain and need for reintervention. The aim is to randomise 128 patients 1:1 to either "separation surgery" followed by SABR (5x 8.0 Gy postoperative) (control arm) vs. SABR alone (5x 8.0 Gy) (study arm). Patients will be evaluated at 3 and 6 months after treatment with MRI scan, quality of life questionnaires, anamnestic and clinical evaluation at clinical follow ups for assessment of ambulatory function, acute and late toxicity and need for reintervention. Moreover, at 6 weeks, 12 months and 24 months after treatment a teleconsult for assessment of ambulatory function, and need for reintervention will be performed.