NCT01752036

Radiotherapy for Solid Tumor Spine Metastases

Phase II Study of Post-Operative Stereotactic Radiosurgery for Solid Tumor Spine Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 12 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Although it is being increasingly used off protocol, there is minimal data regarding the efficacy of stereotactic radiosurgery to the tumor bed following surgical resection of metastatic lesions to the spine. The primary objective of this study is to evaluate radiographic local recurrence in the tumor bed following stereotactic radiosurgery compared to the expected rate following conventional radiation therapy.

Detailed description

This is a phase II trial evaluating the rate radiographic local recurrence following post-operative stereotactic radiosurgery boost in patients with metastatic solid malignancies with spine metastases status post resection. Patients will be treated with 600 cGy x 5 fractions to the tumor bed and then followed both clinically and radiographically to determine if local recurrence following this treatment is better than might be expected for conventional radiation therapy.

Conditions

• Solid Tumor Spine Metastases

Interventions

Type	Name	Description
RADIATION	Post-operative, Stereotactic Body Radiation Therapy (SBRT)	All participants received SBRT at 600 cGy x 5 fractions

Timeline

• Start date: 2013-05-20
• Primary completion: 2018-04-02
• Completion: 2018-07-27
• First posted: 2012-12-18
• Last updated: 2020-06-25
• Results posted: 2020-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study