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Spinal met_radiosurgery/SBRT Study

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ClinicalTrials.gov Identifier: NCT01231061
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Spine Metastasis Radiation: SBRT Radiation: Radiosurgery Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Image-Guided Radiosurgery / SBRT for Localized Spine Metastasis
Study Start Date : November 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: Arm A: SBRT Radiation: SBRT
•24 Gy in 3 fractions to cover at least 90% of the defined target volume

Experimental: Arm B: Radiosurgery Radiation: Radiosurgery
16 Gy in 1 fraction to cover at least 90% of the defined target volume




Primary Outcome Measures :
  1. Pain control at 3 months post-treatment [ Time Frame: 4 years ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Zubrod Performance Status 0-2;
  3. Age ≥ 18;
  4. History/physical examination within 2 weeks prior to registration;
  5. No pregnancy for women of childbearing potential;
  6. 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.
  7. 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.
  8. 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).
  9. Patients with epidural compression are eligible provided that there is no significant displacement or compression on the spinal cord itself.
  10. Patients with a paraspinal mass ≤ 5 cm in the greatest dimension and that is contiguous with spine metastasis are eligible.
  11. Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

  1. Histologies of myeloma or lymphoma.
  2. Patients with any spine metastasis with a rating of < 4 on the Numerical Rating Pain Scale.
  3. Non-ambulatory patients.
  4. Spine instability due to a compression fracture.
  5. > 50% loss of vertebral body height.
  6. Significant spinal cord compression or displacement.
  7. Patients with rapid neurologic decline.
  8. Bony retropulsion causing neurologic abnormality.
  9. Prior radiation to the index spine.
  10. Patients for whom an MRI of the spine is medically contraindicated.

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 ClinicalTrials.gov identifier (NCT number): NCT01231061


Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Michael KM KAM, FRCP Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong

Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01231061     History of Changes
Other Study ID Numbers: SYM008
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014

Keywords provided by CCTU, Chinese University of Hong Kong:
spine metastasis
SBRT
Radiosurgery

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes