Study Comparing Stereotactic Body Radiation Therapy vs Conventional Palliative Radiation Therapy (CRT) for Spinal Metastases

Official Title

A Randomized Phase II/III Study Comparing Stereotactic Body Radiation Therapy(SBRT) Versus Conventional Palliative Radiation Therapy (CRT) for Patients With Spinal Metastases

Summary:

The purpose of this study is to find out if SBRT is better than CRT at controlling pain in the spine 3 months after receiving treatment.

Trial Description

Primary Outcome:

  • The ability to randomize 54 patients with spinal metastases in Phase 2 measured by number of patients randomized to the trial
  • Phase III: Complete pain response measured by the Cochran-Mantel-Hanzeal test
Secondary Outcome:
  • Complete pain response based on the International Bone Metastases Consensus Working Party Criteria
  • Radiation site progression-free survival using MRI imaging
  • Number and severity of adverse events using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0)
  • Health-related Quality of Life measured by the EORTC QLQ-C30 and QLQ-BM22 instruments
  • Radiotherapy Quality Assurance compliance consisting of investigator credentialing, Prospective centre based individual pre-treatment case review and Retrospective external individual post-treatment case review.
This research is being done because while there is some evidence suggesting that SBRT may improve treatment for patients with spine metastases, more research is needed to determine if it is better than CRT. The first part of the randomized trial (phase II) looked at whether it was possible (feasible) to provide these treatments in cancer centres across Canada, by aiming to recruit 54 participants within 18 months. This part of the study was successfully completed in early 2017. The second component of this study, called a randomized phase III trial, is now underway. It involves recruiting another 98 participants to receive either CRT or SBRT, using the same study procedure as in the feasibility study. We will continue to obtain information about whether SBRT is better than CRT at controlling pain.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society