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 range50 Years

SexALL

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

What they're measuring

pain evaluation

Timeframe: day 1

Trial details

NCT IDNCT02773966

SponsorUniversitätsmedizin Mannheim

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-06

View on ClinicalTrials.gov More Metastasis trials