Kypho-IORT: Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases (Kypho-IORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01280032
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : November 13, 2013
Information provided by (Responsible Party):
Frederik Wenz, Universitätsmedizin Mannheim

Brief Summary:

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 or disease Intervention/treatment Phase
Tumors Radiation: intraoperative radiotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Kypho-IORT: Phase II Study for Dose Escalation of Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases
Study Start Date : January 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: Kypho-IORT Radiation: intraoperative radiotherapy
intraoperative radiotherapy (8 Gy) during kyphoplasty for spinal metatsases

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Efficacy defined by CT or MR-imaging and / or clinical relapses / progress and pain [ Time Frame: 5 years ]

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01280032

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Frederik Wenz, Prof. Dr. med., Universitätsmedizin Mannheim Identifier: NCT01280032     History of Changes
Other Study ID Numbers: MA-Kypho-IORT-01
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Frederik Wenz, Universitätsmedizin Mannheim:
intraoperative radiotherapy
spinal metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes