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Study of Image-Guided SBRT for Vertebral Metastases

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02616887
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : December 19, 2019
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas

Brief Summary:
Based on the known efficacy of ablative single dose SBRT and VMAT technique in various solid tumors, investigators have designed this study to assess feasibility of SBRT in selected patients with spine metastases.

Condition or disease Intervention/treatment
Vertebral Metastases Radiation: Single dose SBRT and VMAT technique

Detailed Description:

This is a prospective, phase 2 study. The main objectives are to assess acute and late side effects of single fraction SBRT for selected patients with vertebral metastases and to study the local control of disease in treated sites.

The schedule will be 1 fraction of 18 Gy delivered in one day with Volumetric Modulated Arc Therapy (VMAT) and Flattening filter-free (FFF) beams.

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Study Type : Observational
Estimated Enrollment : 59 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase II Study of Image-Guided Single Fraction SBRT With VMAT-FFF Technique for Vertebral Metastases
Actual Study Start Date : November 5, 2015
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Group/Cohort Intervention/treatment
Vertebral metastases
Selected patients with spine metastases are treated with ablative single dose SBRT and VMAT technique in various solid tumors .
Radiation: Single dose SBRT and VMAT technique
One fraction of 18 Gy delivered in one day with VMAT and Flattening filter-free (FFF) beams.

Primary Outcome Measures :
  1. Toxicity of single fraction SBRT on spine metastases using CTCAE v.4 [ Time Frame: 1 year ]
  2. Local control of the treated lesions using Kaplan-Meyer statistical curves [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Pain control at treated sites after RT using CTCAE v.4 [ Time Frame: 3 months ]
  2. Local control of the metastatic disease using Kaplan-Meyer statistical curves [ Time Frame: 3 months ]
  3. Overall survival of treated patients using Kaplan-Meyer statistical curves [ Time Frame: 1 year ]
  4. Difference of local and pain control between patients operated on vertebra and non-operated patients using CTCAE v.4 [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with spine metastases

Inclusion Criteria:

  • Age ≥ 18years.
  • WHO performance status ≤ 2 (ECOG - KPS).
  • Histologically-proven of primary cancer disease.
  • Metastatic disease in the spine, from C1 to Sacrum. A maximum number of 5 sites. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies.
  • Epidural compression is eligible when there is at least 3 mm gap between the spinal cord and the edge of the epidural lesion, unless patient underwent decompression surgery.
  • A paraspinal mass ≤ 5 cm.
  • Minimal residual tumor after surgery
  • Metastases in other district of the body are allowed.
  • Informed consent.

Exclusion Criteria:

  • > 50% loss of vertebral body height.
  • Prior radiation to the interested spine.
  • Patients for whom an MRI of the spine is medically contraindicated.
  • Patients allergic to contrast used in MRIs or CT scans or who cannot be premedicated for the use of contrast.

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): NCT02616887

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Contact: Ciro Franzese, MD +390282247454

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Humanitas Research Hospital Recruiting
Rozzano, Milan, Italy, 20089
Contact: Ciro Franzese, MD    +390282247454   
Sub-Investigator: Piera Navarria, MD         
Sub-Investigator: Francesco Costa, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas
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Principal Investigator: Ciro Franzese, MD Istituto Clinico Humanitas
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Responsible Party: Michele Tedeschi, MD, Istituto Clinico Humanitas Identifier: NCT02616887    
Other Study ID Numbers: 1460
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes