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

Launched by CANCER RESEARCH ANTWERP · Sep 23, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating two treatment options for patients with spinal tumors that are pressing on the spinal cord, a condition known as malignant epidural spinal cord compression (MESCC). The study is comparing the effectiveness of a procedure called separation surgery followed by a type of targeted radiation therapy called stereotactic ablative body radiotherapy (SABR) against using SABR alone. The main goal is to see which option helps patients maintain their ability to walk three months after treatment.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with a solid malignant tumor that has spread to the spine. They should still be able to walk, either independently or with some assistance. The trial will enroll 128 patients, who will be randomly assigned to one of the two treatment groups. Throughout the study, participants will have regular check-ups, including MRI scans and questionnaires, to monitor their progress, quality of life, and any side effects. This research aims to find the most effective treatment to help patients maintain mobility and overall well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of a solid malignant tumour (preferentially histologically proven;alternatively obtained by spinal surgical procedure)
• • Age 18 years or older
• • Histological, radiological or scintigraphical evidence of spinal metastasis (no limitation in the number of sites of metastases)
• • Spinal instability neoplastic score (SINS) \<13 (i.e. no need for stabilisation of the spine) (see Appendix 6)
• • Spinal metastasis with MESCC: ESCC grade 1c, 2 and 3 (see Appendix 7)
• • Ambulatory: being able to walk 10m without aid or with aid (cane, rollator, one persons help).
• • Life expectancy estimated to be at least 3 months.
• • World Health Organization (WHO) Performance Status of 0-2 (some help) (see Appendix 3)
• • Patient has given written informed consent.
• Exclusion Criteria:
• • Contra indication for MRI scan (e.g. pacemaker)
• • Previous RT or surgery at the level of the affected vertebrae
• • Non-solid primary tumours (e.g. lymphoma, multiple myeloma, germ cell tumours)
• • Non ambulatory at presentation
• • More than 3 affected vertebrae in one target site
• • More than 2 treatment sites
• • SINS ≥ 13 (unstable spine)