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

Primary Phase II Component Determine the feasibility of successfully delivering image-guided radiosurgery/SBRT for spine metastases in a cooperative group setting Phase III Component Determine whether image-guided radiosurgery/SBRT (single dose of 16 or 18 Gy) improves pain control (as measured by the 11 point NRPS) as compared to conventional external beam radiotherapy (single dose of 8 Gy) The endpoint is complete or partial pain relief at the treated index site at 3 months, (as measured by the 11 point NRPS). Complete pain relief is defined as a score of 0 on the NRPS, with no increase in narcotic pain medication. Partial pain relief is defined as an improvement from the baseline NRPS of at least 3 points on the rating scale (and no progressive pain response at any other treated lesion[s], with no increase in narcotic pain medication). Secondary (Phase III component) Determine whether image-guided radiosurgery/SBRT improves the rapidity of pain response at the treated site(s) as compared to conventional external beam radiotherapy, as measured by the NRPS; Determine whether image-guided radiosurgery/SBRT increases the duration of pain response at the treated site(s), as compared to conventional external beam radiotherapy, as measured by the NRPS; Compare adverse events between the two treatments according to the criteria in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0; Evaluate the long-term effects (24 months) of image-guided radiosurgery/SBRT on the vertebral bone (such as compression fracture) and the spinal cord by MRI; Evaluate the potential benefit of image-guided radiosurgery/SBRT on change in and overall quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACTG); in pain as measured by the Brief Pain Inventory (BPI); and in health utilities as measured by the EuroQol (EQ-5D); To implement a well-controlled specimen handling/storage process to facilitate future laboratory correlative studies.

Primary Phase II Component Determine the feasibility of successfully delivering image-guided radiosurgery/SBRT for spine metastases in a cooperative group setting Phase III Component Determine whether image-guided radiosurgery/SBRT (single dose of 16 or 18 Gy) improves pain control (as measured by the 11 point NRPS) as compared to conventional external beam radiotherapy (single dose of 8 Gy) The endpoint is complete or partial pain relief at the treated index site at 3 months, (as measured by the 11 point NRPS). Complete pain relief is defined as a score of 0 on the NRPS, with no increase in narcotic pain medication. Partial pain relief is defined as an improvement from the baseline NRPS of at least 3 points on the rating scale (and no progressive pain response at any other treated lesion[s], with no increase in narcotic pain medication). Secondary (Phase III component) Determine whether image-guided radiosurgery/SBRT improves the rapidity of pain response at the treated site(s) as compared to conventional external beam radiotherapy, as measured by the NRPS; Determine whether image-guided radiosurgery/SBRT increases the duration of pain response at the treated site(s), as compared to conventional external beam radiotherapy, as measured by the NRPS; Compare adverse events between the two treatments according to the criteria in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0; Evaluate the long-term effects (24 months) of image-guided radiosurgery/SBRT on the vertebral bone (such as compression fracture) and the spinal cord by MRI; Evaluate the potential benefit of image-guided radiosurgery/SBRT on change in and overall quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACTG); in pain as measured by the Brief Pain Inventory (BPI); and in health utilities as measured by the EuroQol (EQ-5D); To implement a well-controlled specimen handling/storage process to facilitate future laboratory correlative studies.