Study of Image-Guided SBRT for Vertebral Metastases

NCT02616887 | Terminated DMC

• 1 other identifier: 1460
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Vertebral Metastases

Outcome Measures

Primary Outcomes (2)

• Toxicity of single fraction SBRT on spine metastases using CTCAE v.4

  1 year

• Local control of the treated lesions using Kaplan-Meyer statistical curves

  1 year

Secondary Outcomes (4)

• Pain control at treated sites after RT using CTCAE v.4

  3 months

• Local control of the metastatic disease using Kaplan-Meyer statistical curves

  3 months

• Overall survival of treated patients using Kaplan-Meyer statistical curves

  1 year

• Difference of local and pain control between patients operated on vertebra and non-operated patients using CTCAE v.4

  3 months

Study Arms (1)

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

Interventions

Single dose SBRT and VMAT technique RADIATION

One fraction of 18 Gy delivered in one day with VMAT and Flattening filter-free (FFF) beams.

Vertebral metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with spine metastases

You may qualify if:

• 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.

You may not qualify if:

• \> 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ciro Franzese, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 30, 2015
• Study Start: November 5, 2015
• Primary Completion: February 8, 2022
• Study Completion: February 8, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

IT (1)