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Kypho-IORT vs. EBRT in Spinal Metastases

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 by Frederik Wenz, Universitätsmedizin Mannheim
Sponsor:
Information provided by (Responsible Party):
Frederik Wenz, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier:
NCT02773966
First received: May 4, 2016
Last updated: July 14, 2016
Last verified: July 2016
  Purpose
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).

Condition Intervention Phase
Metastasis Radiation: Kypho-IORT Radiation: EBRT Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intraoperative Radiotherapy During Kyphoplasty/Vertebroplasty (Kypho-IORT) Versus EBRT in the Treatment of Painful Vertebral Metastases - a Randomized Prospective Phase III Study -

Further study details as provided by Frederik Wenz, Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • pain evaluation [ Time Frame: day 1 ]
    Evaluation of the percentage of patients with a pain reduction of VAS-3 points after Kypho-IORT vs. EBRT at day 1 (one day after Kypho-IORT; one day after the first EBRT)


Secondary Outcome Measures:
  • pain evaluation [ Time Frame: week 2, 6 weeks after start of treatment ]
    Evaluation of the percentage of patients with a pain reduction of VAS-3 at week 2 and 6 weeks after start of treatment

  • local recurrence rate [ Time Frame: 6 weeks, then after 3 months, then every 6 months up to 5 years ]
    local recurrence diagnosed by a MRI or CT scan

  • Quality of life (QoL) questionaire [ Time Frame: before start of therapy and then 6 weeks, then after 3 months, then every 6 months up to 5 years ]
    Assessed by European Organization for Research and Treatment (EORTC)-Quality of Life questionaires (QLQ-C30/BM22)

  • Overall survival [ Time Frame: 12 Months ]
    Overall survival will be calculated from the date of Kypho-IORT/start of EBRT until the date of death from any cause or date of last follow-up.


Estimated Enrollment: 54
Study Start Date: July 2016
Estimated Study Completion Date: November 2023
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Kypho-IORT
balloon kyphoplasty/vertebroplasty + intraoperative radiotherapy
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.
Active Comparator: Arm B: EBRT
external beam radiotherapy with 30 Gy during 10 days (3 Gy/day)
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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02773966

Contacts
Contact: Frederik Wenz, Prof. +49621/3834960 frederik.wenz@umm.de
Contact: Tina Reis, Dr. med. +49621/3834960 tina.reis@umm.de

Locations
Germany
Department of Radiotherapy University Hospital Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Frederik Wenz, Prof. Dr. med.    00496213834960    frederik.wenz@medma.uni-heidelberg.de   
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
Principal Investigator: Frederik Wenz, Prof. Universitätsmedizin Mannheim
  More Information

Publications:

Responsible Party: Frederik Wenz, Prof. Dr. Frederik Wenz, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT02773966     History of Changes
Other Study ID Numbers: Kypho-IORT/EBRT
Study First Received: May 4, 2016
Last Updated: July 14, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on June 28, 2017