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Kypho-IORT vs. EBRT in Spinal Metastases

NCT02773966 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-07-22

No results posted yet for this study

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).

Conditions

  • Metastasis

Interventions

RADIATION

Kypho-IORT

During kyphoplasty/vertebroplasty a intraoperative radiotherapy of the affected vertebrae is done with a miniature X-ray generator (INTRABEAM®, Carl Zeiss, Surgical, Oberkochen, Germany). The prescription dose will be 8 Gy in a distance of 13 mm from the isocenter of the radiation source. IORT will take about five minutes. After radiation the applicator will be removed and the operation will be finished as usual.

RADIATION

EBRT

The external beam radiotherapy will be usually carried out as an outpatient procedure. All patients will receive a planning CT before the first irradiation. EBRT will be performed with 30 Gy, added in 3 Gy per fraction or 8 Gy single dose (only for international study centers, not permitted in Germany) on a conventional linear accelerator (LINAC).

Sponsors & Collaborators

  • Universitätsmedizin Mannheim

    lead OTHER

Principal Investigators

  • Frank Giordano, MD · Universitätsmedizin Mannheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-12
Primary Completion
2020-03-06
Completion
2020-03-06

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02773966 on ClinicalTrials.gov