Clinical trial · Observational
Postoperative Edge (RapidArc) Stereotactic Body Radiotherapy for Spinal Metastases
Prognostic Study of Postoperative Edge (RapidArc) Stereotactic Body Radiotherapy for Spinal Metastases From Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study observes the effectiveness of high-precision radiation therapy using the Edge system after surgery for patients with spinal metastases. Spinal metastases can press on the spinal cord and cause pain, weakness, or paralysis. This treatment uses higher doses of radiation in fewer sessions (hypofractionated stereotactic body radiotherapy) delivered precisely by the Edge machine to target remaining tumor cells while protecting the spinal cord. The study aims to see if this approach improves local tumor control, improves neurological function, shortens treatment duration, and improves quality of life in these patients. The study is observational, meaning patients receive standard care, and data is collected to evaluate the outcomes.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Epidural Spinal Cord Compression | — | UNRESOLVED | — |
| Spinal Cord Compression | — | UNRESOLVED | — |
| Spinal Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Edge SBRT Group
- description
- Participants received postoperative stereotactic body radiotherapy (SBRT) using the Edge system, prescribed as 35 Gy in 5 fractions (7 Gy per fraction).
- interventionNames
- Radiation: Stereotactic Body Radiotherapy
Primary outcomes (1)
- measure
- Local Control Rate (LC)
- timeFrame
- 3 months post-treatment
- description
- Proportion of patients with local tumor control, assessed by MRI showing residual tumor volume changes at 3 months post-treatment.
Secondary outcomes (4)
- measure
- Neurological Deterioration-Free Survival (NDFS)
- timeFrame
- 1 year and 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 to 80 years, any sex. 2. Karnofsky Performance Status (KPS) \>= 60 or ECOG Performance Status \<= 2. 3. Confirmed spinal metastases from solid tumors by pathology or imaging (MRI/CT). 4. Postoperative imaging confirming residual epidural spinal cord compression (MESCC) requiring adjuvant radiotherapy. 5. Number of lesions \<= 5, and maximum diameter of a single lesion \<= 5 cm. 6. Interval between surgery and radiotherapy \<= 4 weeks. 7. Signed informed consent and willingness to participate in the study. Exclusion Criteria: 1. Uncontrolled primary tumor (e.g., extensive metastasis or progressive disease). 2. Concurrent brain metastases or other active malignancies. 3. Pathological fracture or severe spinal instability requiring emergency surgical intervention. 4. Prior cumulative spinal cord radiation dose exceeding the tolerance threshold (e.g., previous spinal cord Dmax \>= 45 Gy). 5. Contraindications to radiotherapy (e.g., severe cardiopulmonary dysfunction, coagulation disorders). 6. Severe postoperative complications (e.g., infection, poor wound healing) requiring delayed radiotherapy. 7. Incomplete or unreliable medical records from external hospitals. 8. Pregnant or lactating women.
References
Publications (1)
- BACKGROUNDGuckenberger M, Andratschke N, Belka C, Bellut D, Cuccia F, Dahele M, Guninski RS, Josipovic M, Mancosu P, Minniti G, Niyazi M, Ricardi U, Munck Af Rosenschold P, Sahgal A, Tsang Y, Verbakel W, Alongi F. ESTRO clinical practice guideline: Stereotactic body radiotherapy for spine metastases. Radiother Oncol. 2024 Jan;190:109966. doi: 10.1016/j.radonc.2023.109966. Epub 2023 Nov 2. PMID 37925107