Hemangioma of Vertebral Column Clinical Trial
Official title:
CyberKnife Based Hypofractionated Radiotherapy Versus Conventional Linac Based Radiotherapy for Painful Vertebral Hemangiomas - Controlled Randomized Clinical Trial.
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
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment