Kypho-IORT vs. EBRT in Spinal Metastases (NCT02773966) | Clinical Trial Compass
TerminatedPhase 3
Kypho-IORT vs. EBRT in Spinal Metastases
Stopped: Slow recruitment
Germany6 participantsStarted 2017-11-12
Plain-language summary
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).
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.