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Kypho-IORT: Phase II Study for Dose Escalation of Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases


Phase 2
50 Years
N/A
Open (Enrolling)
Both
Tumors

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Trial Information

Kypho-IORT: Phase II Study for Dose Escalation of Intraoperative Radiotherapy During Kyphoplasty for Spinal Metastases


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

side effect of IORT using defined MTD criteria: dysfunction of wound healing, infections, osteoradionecrosis, nerve and spinal cord damage, pathological fracture within 90 days

Outcome Time Frame:

5 years

Safety Issue:

No

Authority:

Germany: Ethics Commission

Study ID:

MA-Kypho-IORT-01

NCT ID:

NCT01280032

Start Date:

January 2011

Completion Date:

December 2018

Related Keywords:

  • Tumors
  • intraoperative radiotherapy
  • kyphoplasty
  • spinal metastases
  • Neoplasm Metastasis

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