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NCT06613295: SABR-MESCC
Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases
NA trial testing SABR in Solid Tumor in 128 participants. Currently enrolling.
1 March 2025
Quick facts
| Lead sponsor | Cancer Research Antwerp |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 128 |
| Start date | 7 March 2022 |
| Primary completion | 1 March 2025 |
| Estimated completion | 1 March 2027 |
| Sites | 9 locations across Belgium |
Drugs / interventions tested
- SABR
- Separation surgery
Conditions studied
- Solid Tumor — all drugs for Solid Tumor →
- Spinal Neoplasms — all drugs for Spinal Neoplasms →
- Spinal Tumor — all drugs for Spinal Tumor →
Sponsor
Cancer Research Antwerp — full company profile →
Who can join
18 and older, any sex, with Solid Tumor or Spinal Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06613295
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT05311527 — UroLift System With SAbR for Prostate Cancer and BPH · NA · completed
- NCT05377047 — Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer · NA · recruiting
- NCT04742972 — Prostate PMSABR Study · NA · withdrawn
Other recruiting trials for Solid Tumor
Currently open trials in the same condition.
- NCT07489378 — NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rar · recruiting
- NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
- NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
- NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting
Other Cancer Research Antwerp trials
Trials by the same sponsor.
- NCT06739655 — Preoperative Radiation Therapy and Immediate Breast Reconstruction · NA · recruiting
- NCT06282588 — Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers · Phase 2, PHASE3 · recruiting
- NCT05011500 — Masks Against Surface-Scanning for Radiation Therapy Immobilisation in Head and Neck Cancer (MASSC) · NA · unknown
- NCT03831243 — A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases · NA · completed
- NCT03486431 — A Dose-escalation Trial of Stereotactic Ablative Body Radiotherapy for Non-spine Bone & Lymph Node Oligometastates · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06613295 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cancer Research Antwerp
- Last refreshed: 25 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06613295.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing