Clinical trial · Interventional
Kypho-IORT vs. EBRT in Spinal Metastases
Intraoperative Radiotherapy During Kyphoplasty/Vertebroplasty (Kypho-IORT) Versus EBRT in the Treatment of Painful Vertebral Metastases - a Randomized Prospective Phase III Study -
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment
Summary
Brief summary (as posted)
The objective of this randomized phase III study is to test the superiority of Kypho-IORT compared to EBRT with regard of time to pain reduction in patients with painful vertebral metastases. Therefore patients will receive intraoperative radiotherapy (8 Gy with Intrabeam System/Carl Zeiss) during kyphoplasty (Arm A) or external beam radiotherapy with 30 Gy, added in 3 Gy per fraction on a conventional linear accelerator or 8 Gy single dose (only for international study centers, not permitted in Germany) (Arm B).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EBRT | Radiation | — | UNRESOLVED |
| Kypho-IORT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Kypho-IORT
- description
- balloon kyphoplasty/vertebroplasty + intraoperative radiotherapy
- interventionNames
- Radiation: Kypho-IORT
- type
- ACTIVE_COMPARATOR
- label
- Arm B: EBRT
- description
- external beam radiotherapy with 30 Gy during 10 days (3 Gy/day)
- interventionNames
- Radiation: EBRT
Primary outcomes (1)
- measure
- pain evaluation
- timeFrame
- day 1
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 50 years * Karnofsky Index ≥ 60 * Initial pain score using the VAS ≥ 3 under standard pain medication * Histological or by imaging proven painful osteolytic metastases (max. 4 treatable vertebrae) of the thoracic/lumbar spine, which are accessible for Kypho-IORT * Written informed consent obtained * Exclusion Criteria: * Previous local treatment (irradiation, surgery) * Cranial site of the metastasis above T4 * Pathological fracture with sintering \>50% * Purely osteoblastic metastasis * Intraspinal extension * Erosion of the bony borders of the vertebra which make a cement filling difficult, rated by the treating surgeon * Tumor expansion to dorsal vertebral structures (pedicle, lamina) * Pregnancy/lactation
References
Publications (11)
- BACKGROUNDGerszten PC, Mendel E, Yamada Y. Radiotherapy and radiosurgery for metastatic spine disease: what are the options, indications, and outcomes? Spine (Phila Pa 1976). 2009 Oct 15;34(22 Suppl):S78-92. doi: 10.1097/BRS.0b013e3181b8b6f5. PMID 19829280
- BACKGROUNDSouchon R, Wenz F, Sedlmayer F, Budach W, Dunst J, Feyer P, Haase W, Harms W, Sautter-Bihl ML, Sauer R; German Society of Radiation Oncology (DEGRO). DEGRO practice guidelines for palliative radiotherapy of metastatic breast cancer: bone metastases and metastatic spinal cord compression (MSCC). Strahlenther Onkol. 2009 Jul;185(7):417-24. doi: 10.1007/s00066-009-2044-2. Epub 2009 Aug 28. PMID 19714302
- BACKGROUNDBerenson J, Pflugmacher R, Jarzem P, Zonder J, Schechtman K, Tillman JB, Bastian L, Ashraf T, Vrionis F; Cancer Patient Fracture Evaluation (CAFE) Investigators. Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):225-35. doi: 10.1016/S1470-2045(11)70008-0. Epub 2011 Feb 16. PMID 21333599
- BACKGROUNDSchneider F, Greineck F, Clausen S, Mai S, Obertacke U, Reis T, Wenz F. Development of a novel method for intraoperative radiotherapy during kyphoplasty for spinal metastases (Kypho-IORT). Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):1114-9. doi: 10.1016/j.ijrobp.2010.07.1985. Epub 2010 Oct 8. PMID 20934272
- BACKGROUNDWenz F, Schneider F, Neumaier C, Kraus-Tiefenbacher U, Reis T, Schmidt R, Obertacke U. Kypho-IORT--a novel approach of intraoperative radiotherapy during kyphoplasty for vertebral metastases. Radiat Oncol. 2010 Feb 11;5:11. doi: 10.1186/1748-717X-5-11. PMID 20149237
- BACKGROUNDSchmidt R, Wenz F, Reis T, Janik K, Bludau F, Obertacke U. Kyphoplasty and intra-operative radiotheray, combination of kyphoplasty and intra-operative radiation for spinal metastases: technical feasibility of a novel approach. Int Orthop. 2012 Jun;36(6):1255-60. doi: 10.1007/s00264-011-1470-9. Epub 2012 Jan 22.