NCT01347307

Stereotactic Body Radiotherapy for Spine Tumors

Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Spine Metastases and Primary Spine Tumors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Mercy Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors.

Detailed description

This study is a single site, non-randomized, prospective, phase IV trial. Patients are composed of 2 groups:Spine Metastases OR Benign Spine Tumors. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years

Conditions

• Spinal Metastases
• Vertebral Metastases
• Benign Spinal Tumors
• Chordoma
• Meningioma
• Schwannoma
• Neurofibroma
• Paragangliomas
• Arteriovenous Malformations

Interventions

Type	Name	Description
RADIATION	SBRT for Benign Extradural Spine Tumors	14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
RADIATION	SBRT for Vertebral/Paraspinal Metastases	12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)

Timeline

• Start date: 2008-09-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2011-05-04
• Last updated: 2020-06-18
• Results posted: 2020-06-18

Locations

1 site across 1 country: United States