Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Metastatic spine cancer incidence is increasing; the primary treatment is radiation therapy. Metastatic spine disease has been historically treated with external beam radiation therapy (EBRT) with conventional fractionation, yielding relatively limited durability in pain control. The increased lifespan of patients with metastatic cancer has resulted in an increase in the incidence of spine metastases, which has led to a need for more durable treatment results. Stereotactic radiosurgery (SRS)/Stereotactic body radiation therapy (SBRT) of the spine has exponentially increased, with the theoretical advantages of higher tumoricidal dose and more rapid fall off between tumor and surrounding normal tissue compared with EBRT. The goal of this study is to compare three types of radiation therapy to draw conclusions on what is an effective treatment to reduce pain and increase pain freedom rates. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05617716
Study type Interventional
Source Case Comprehensive Cancer Center
Contact Shearwood McClelland III, MD
Phone 1-800-641-2422
Email CTUReferral@UHhospitals.org
Status Recruiting
Phase Phase 2
Start date January 25, 2023
Completion date December 31, 2026

See also
  Status Clinical Trial Phase
Not yet recruiting NCT02226289 - Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment Phase 2
Terminated NCT02566421 - Genomic Sequencing in Determining Treatment in Patients With Metastatic Cancer or Cancer That Cannot Be Removed by Surgery N/A
Completed NCT01606033 - Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating N/A
Terminated NCT04418661 - Safety and Efficacy Study of SAR442720 in Combination With Other Agents in Advanced Malignancies Phase 1/Phase 2
Completed NCT00525057 - Dalteparin in Preventing DVT in Participants With Cancer N/A
Terminated NCT03871348 - A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors Phase 1
Completed NCT02775292 - Gene-Modified T Cells, Vaccine Therapy, and Nivolumab in Treating Patients With Stage IV or Locally Advanced Solid Tumors Expressing NY-ESO-1 Phase 1
Active, not recruiting NCT05103358 - Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1) Phase 2
Recruiting NCT02560311 - Long-term Outcome of HER2-amplified Metastatic Breast Cancer: A Retrospective Analysis N/A
Completed NCT02492711 - Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer Phase 3