At a glance
ClinicalIndex Comparison Record- ✓Histologic confirmation of malignancy and imaging confirmation of spinal metastatic disease
- ✓No prior therapies for this disease, including radiation therapy to the anatomic site to be treated
- ✓Age greater than 18 years
- ✓Life expectancy of at least 3 months
- ✕Receiving any other investigational agents
- ✕Prognosis less than 3 months
- ✕Uncontrolled intercurrent illness including infection, congestive heart failure, angina, arrhythmia, or psychiatric illness
- ✕Pregnant or nursing
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) Multicenter Randomized Phase II Clinical Trial
In Brief
A Phase 2 clinical trial evaluating Conventional external beam radiation therapy dose (EBRT), Spine radiosurgery/stereotactic body radiation therapy standard dose, and 1 other intervention for Metastatic Neoplasm to the Spine and Metastatic Neoplasm. Currently recruiting, targeting 240 participants across 2 sites.
Detailed Summary
The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT). EBRT delivers tightly targeted radiation beams from outside the body. SBRT is a specialized type of radiation therapy that allows high doses of radiation to small targets. This study will include standard dose SBRT and higher dose SBRT. Each participant will be randomly assigned to either EBRT, standard dose SBRT, or higher dose SBRT.
Study Details
Timeline
Interventions
Participants will undergo 8 Gray in 1 fraction of EBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.
Participants will undergo 24 Gray in 2 fractions of SBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.
Participants will undergo 19 Gray in 1 fraction of SBRT. Questionnaires (brief pain inventory, COST-FACIT, EuroQol EQ-5D) will be administered at baseline, and again at 3,6,9,12 month follow-up.