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Completed

NCT Number: NCT01231061

Spinal met_radiosurgery/SBRT Study

Demonstrate the technical feasibility of treating spine metastases with image-guided radiosurgery/SBRT

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient must have localized spine metastasis from the C1 to L5 levels by a screening imaging study (bone scan, PET, CT, or MRI). A solitary spine metastasis; two separate spine levels; or up to 3 separate sites are permitted. Each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies. A paraspinal mass ≤ 5 cm is allowed.
  • Zubrod Performance Status 0-2;
  • Age ≥ 18;
  • History/physical examination within 2 weeks prior to registration;
  • No pregnancy for women of childbearing potential;
  • MRI of the involved spine within 4 weeks prior to registration to determine the extent of the spine involvement. MRI is required as it is superior to a CT scan in delineating the spinal cord as well as identifying an epidural or paraspinal soft tissue component. If possible, an MRI with thin slice thickness (<1mm) with 3D reconstruction quality would be most preferable for treatment planning purpose.
  • Numerical Rating Pain Scale within 1 week prior to registration. The patient must have a score on the Scale of ≥ 4 for at least one of the planned sites for spine radiosurgery. Patients taking medication for pain at the time of registration are eligible.
  • Neurological examination within 1 week prior to registration to rule out rapid neurologic decline; see Appendix IV for the standardized neurological examination. Patients with mild to moderate neurological signs are eligible. These neurological signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function).
  • Patients with epidural compression are eligible provided that there is no significant displacement or compression on the spinal cord itself.
  • Patients with a paraspinal mass ≤ 5 cm in the greatest dimension and that is contiguous with spine metastasis are eligible.
  • Patients must provide study specific informed consent prior to study entry.

Exclusion criteria

  • Histologies of myeloma or lymphoma.
  • Patients with any spine metastasis with a rating of < 4 on the Numerical Rating Pain Scale.
  • Non-ambulatory patients.
  • Spine instability due to a compression fracture.
  • > 50% loss of vertebral body height.
  • Significant spinal cord compression or displacement.
  • Patients with rapid neurologic decline.
  • Bony retropulsion causing neurologic abnormality.
  • Prior radiation to the index spine.
  • Patients for whom an MRI of the spine is medically contraindicated.

Treatment and study plan

SBRT

Radiation

•24 Gy in 3 fractions to cover at least 90% of the defined target volume

Radiosurgery

Radiation

16 Gy in 1 fraction to cover at least 90% of the defined target volume

Primary outcomes

  1. Pain control at 3 months post-treatment

    Time frame: 4 years

Secondary outcomes

  1. Determine the time of onset of pain response of the responders at the treated site(s) using radiosurgery/SBRT

    Time frame: 4 years

  2. Determine the duration of pain response at the treated site(s) using radiosurgery/SBRT

    Time frame: 4 years

  3. Study the adverse events of radiosurgery/SBRT according to the criteria in the CTEP Active Version of the CTCAE

    Time frame: 4 years

  4. Evaluate the radiological response of image-guided radiosurgery/SBRT by RECIST MRI

    Time frame: 4 years

  5. 2-year Tumor Control Rate

    Time frame: 4 years

  6. Overall Survival

    Time frame: 4 years

  7. Quality of life assessment

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Randomized Phase II Study of Image-Guided Radiosurgery / SBRT for Localized Spine Metastasis

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 1, 2010
Registry last updated
Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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