NCT01849510

Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost

Efficacy of Dose Intensified Radiotherapy of Spinal Metastases of Solid Tumors by Dose Increased, Homogeneous Radiation of Vertebral Body and Simultaneous Application of Stereotactic Boost.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Spinal metastases indicate for an incurable course of disease. Local tumor control after palliative radiotherapy of spinal metastases (10x3 Gy, 1x8Gy) is between 61 to 81%. In 30% of patients, therapy fails locally within two years associated with further symptoms that are difficult to treat, because a further radiation of already radiated vertebra leads to a higher rate of myelitis. This trial aims to improve local tumor control and control of pain by radiotherapy with increase in total and single dose. Dose elevation is realized by simultaneous, integrated boost mediated by image-guided stereotactic radiotherapy (IGRT \& hfSRT) and by elevation of elective dose in vertebral body with 12x3 Gy (standard: 10x3 Gy). Primary endpoint is local tumor control (time up to progression). Secondary endpoints are pain control associated with quality of live, severity of acute and chronic adverse effects and overall survival. It is planned to recruit a total number of 155 patients.

Conditions

• Spinal Metastases

Interventions

Type	Name	Description
RADIATION	hypofractionated 12x3 Gy + integrated boost 12x4 Gy	hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT \& hfSRT
RADIATION	hypofractionated 10x3 Gy	hypofractionated, homogeneous radiation (10x3 Gy)

Timeline

• Start date: 2013-03-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2013-05-08
• Last updated: 2017-08-11

Locations

3 sites across 1 country: Germany