Kypho-IORT: Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases (Kypho-IORT)
Primary Purpose
Tumors
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
intraoperative radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Tumors focused on measuring intraoperative radiotherapy, kyphoplasty, spinal metastases
Eligibility 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
Sites / Locations
- Department of Radiotherapy University Hospital Mannheim
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Kypho-IORT
Arm Description
Outcomes
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
Secondary Outcome Measures
Efficacy defined by CT or MR-imaging and / or clinical relapses / progress and pain
Full Information
NCT ID
NCT01280032
First Posted
January 19, 2011
Last Updated
July 19, 2022
Sponsor
Universitätsmedizin Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT01280032
Brief Title
Kypho-IORT: Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases
Acronym
Kypho-IORT
Official Title
Kypho-IORT: Phase II Study for Dose Escalation of Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsmedizin Mannheim
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumors
Keywords
intraoperative radiotherapy, kyphoplasty, spinal metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kypho-IORT
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
intraoperative radiotherapy
Intervention Description
intraoperative radiotherapy (8 Gy) during kyphoplasty for spinal metatsases
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Efficacy defined by CT or MR-imaging and / or clinical relapses / progress and pain
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Radiotherapy University Hospital Mannheim
City
Mannheim
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33183307
Citation
Bludau F, Winter L, Welzel G, Obertacke U, Schneider F, Wenz F, Ruder AM, Giordano FA. Long-term outcome after combined kyphoplasty and intraoperative radiotherapy (Kypho-IORT) for vertebral tumors. Radiat Oncol. 2020 Nov 12;15(1):263. doi: 10.1186/s13014-020-01715-z.
Results Reference
result
PubMed Identifier
28962909
Citation
Bludau F, Welzel G, Reis T, Schneider F, Sperk E, Neumaier C, Ehmann M, Clausen S, Obertacke U, Wenz F, Giordano FA. Phase I/II trial of combined kyphoplasty and intraoperative radiotherapy in spinal metastases. Spine J. 2018 May;18(5):776-781. doi: 10.1016/j.spinee.2017.09.011. Epub 2017 Sep 28.
Results Reference
result
Learn more about this trial
Kypho-IORT: Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases
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