Kypho-IORT: Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frederik Wenz, University Hospital Mannheim
ClinicalTrials.gov Identifier:
NCT01280032
First received: January 19, 2011
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

Vertebral column is the most prevalent location of bone metastases. Besides axial pain, vertebral metastases cause pathological fracture and neurological dysfunction by spinal cord compression. Although the median overall survival of patients with bone metastases is only 7-9 month, half of them live longer and will require palliative treatment for their symptoms.

Treatment options are radiotherapy and /or surgical treatment such as laminectomy, vertebroplasty or kyphoplasty. Various studies have shown the superiority of postoperative external beam radiotherapy after kyphoplasty in spinal metastases compared to surgery or radiotherapy alone. Nevertheless postoperative radiation schedules last 2-4 weeks. Moreover many patients present visceral and bone metastases simultaneously and require urgent systemic therapy. However, due to potentiated toxicity, concurrent therapy with full dose chemotherapy and radiotherapy is rarely possible.

The investigators have therefore established a novel method for intraoperative radiotherapy (IORT) during kyphoplasty which enables immediate stability, sterilization of the metastasis and immediate initiation of chemotherapy.

The kyphoplasty itself is performed according to the standard procedure with some minor modifications. In short under general anaesthesia, a bipedicular approach into the affected vertebra is chosen with insertion of specially designed metallic sleeves to guide the electron drift tube of the miniature X-ray generator (INTRABEAM®). To perform the IORT during a kyphoplasty with this device a new applicator was designed. This sterile applicator consists of a plastic head, which is needed to attach it to the X-ray source and a stainless steel tube. This tube protects the probe from bending. Under fluoroscopic guidance the applicator including the drift tube is guided through the metallic sleeves in the vertebral body. A dose of 8 Gy in 5 mm distance is delivered. After IORT the INTRABEAM system is removed. The kyphoplasty balloon is inflated and PMMA-cement is injected. Afterwards the sleeves are removed and the wound is closed as usual.

Aim of this study is the definition of the maximum tolerable dose (MTD) for IORT during a kyphoplasty using specific MTD-criteria and evaluating the effectiveness of this combined treatment procedure. To determine the MTD 3 levels with increasing doses are planned:

8 Gy in 5 mm distance, 8 Gy in 8 mm distance and 8 Gy in 10 mm distance.


Condition Intervention Phase
Tumors
Radiation: intraoperative radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Kypho-IORT: Phase II Study for Dose Escalation of Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases

Further study details as provided by Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • side effect of IORT using defined MTD criteria: dysfunction of wound healing, infections, osteoradionecrosis, nerve and spinal cord damage, pathological fracture within 90 days [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy defined by CT or MR-imaging and / or clinical relapses / progress and pain [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: January 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kypho-IORT Radiation: intraoperative radiotherapy
intraoperative radiotherapy (8 Gy) during kyphoplasty for spinal metatsases

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 50 years
  • Karnofsky Index ≥ 60
  • histological or by imaging proven spinal metastases (2 cm diameter as the upper limit) inferior TH 3, which are accessible for kyphoplasty
  • written informed consent obtained
  • use of adequate contraceptive method by female patients of reproductive potential to minimize risk of pregnancy

Exclusion Criteria:

  • uncontrolled intercurrent medical disorder - including but not limited to ongoing or active infection (including infections in the area of the treated spinal segment, for example, spondylitis / osteomyelitis / skin infections) or mental illness / social situation which affect the compliance of study requirements
  • prior radiation of the same vertebra
  • patients could not receive anaesthesia or surgery for medical reasons
  • history of coagulation disorder associated with bleeding
  • existing contraindications for MRI- or CT-scans
  • pregnant or breast-feeding women
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01280032

Locations
Germany
Department of Radiotherapy University Hospital Mannheim
Mannheim, Germany
Sponsors and Collaborators
Universitätsmedizin Mannheim
  More Information

No publications provided

Responsible Party: Frederik Wenz, Prof. Dr. med., University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT01280032     History of Changes
Other Study ID Numbers: MA-Kypho-IORT-01
Study First Received: January 19, 2011
Last Updated: November 12, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsmedizin Mannheim:
intraoperative radiotherapy
kyphoplasty
spinal metastases

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

ClinicalTrials.gov processed this record on September 16, 2014