NCT02332408

CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas

CyberKnife Based Hypofractionated Radiotherapy Versus Conventional Linac Based Radiotherapy for Painful Vertebral Hemangiomas - Controlled Randomized Clinical Trial.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology · Academic / Other
• Sex: All
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Clinical objective of the study is to compare the analgesic effect, toxicity and pathologic effect in the tumors of two radiotherapy schedules used for patients suffering from painful vertebral haemangiomas

Detailed description

Hemangiomas are frequent vertebral lesions (12% of the whole human population) but only 1% displays any clinical symptoms . The most common symptom is local pain, usually non responding for non-steroid anti-inflammatory drugs. Radiation therapy usually does not result calcification or the tumor regression, but significantly reduces the pain intensity or eliminates it. Currently, the most common RT schedule is conventional radiotherapy using fraction dose (fd) of 2 Gy delivered to the total dose (TD) varying from36 Gy to 40 Gy. The results in pain reduction achieved after larger total doses are better that led us to use radioablative techniques. This procedure is associated with a probability of better analgesic effect and the good local effect (calcification and / or regression of laesion) with high safety of radiation delivery using tracking based cybernetic microradiosurgery (CyberKnife). The comparison of two modalities of radiation therapy (conventional \[fd 2 Gy, TD 36 Gy\] and hypofractionated \[fd 5 Gy, TD 25 Gy\]) used for treatment of painful vertebral hemangioma patients will be performed in the phase III randomized study. 80 patients will be enrolled in this study. All patients will be planned (RT) on the base of CT/MRI fusion. Patients will be controlled 1, 3, 6, 9, 12 months after treatment completion and, next every each 6 months. Pain relief, analgesics uptake, local effect (MRI and Technetium - 99m-labelled RBC(red blood cell) scintigraphy) and eventual toxicity will be checked during follow-up (FU).

Conditions

• Hemangioma of Vertebral Column

Interventions

Type	Name	Description
RADIATION	Cybernetic microradiosurgery	Cybernetic microradiosurgery (6MV) using tracking to TD 25Gy given in five fraction (5Gy p fr) two or three days a week, during 2 weeks
RADIATION	Conventional radiotherapy	Conventionally fractionated linac based external beam radiation therapy - EBRT, (conformal or dynamic) to the TD of 36 Gy, in 2.0 Gy per fraction 5 days a week over the period of 3.5 weeks)

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-09-01
• Completion: 2021-09-01
• First posted: 2015-01-06
• Last updated: 2015-01-06

Locations

1 site across 1 country: Poland