Clinical Trial: CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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).


Sponsor: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Current Primary Outcome: Analgetic effect [ Time Frame: 2 years ]

rate of pain relief


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Identification of radiologic prognostic and predictal factors of response to external beam radiotherapy (radiosurgery compared to conventional) [ Time Frame: 2 years ]
  • Identification of biochemical and physical prognostic factors of response to external beam radiotherapy (radiosurgery compared to conventional) [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Dates:
Date Received: January 4, 2015
Date Started: September 2014
Date Completion: September 2021
Last Updated: January 4, 2015
Last Verified: January 2015