CyberKnife Based Hypofractionated Radiotherapy for Vertebral Hemangiomas

Hemangioma of Vertebral Column Clinical Trial

— CKHRTVH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02332408
• Other study ID #: HRVH-COI-03
• Status: Recruiting
• Phase: Phase 3
• First received: January 4, 2015
• Last updated: January 4, 2015
• Start date: September 2014
• Est. completion date: September 2021

Study information

• Verified date: January 2015
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: Leszek Miszczyk, MD, PhD
• Phone: 0048322788001
• Email: leszek[@]io.gliwice.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2021
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Confirmed vertebral hemangioma ,

2. Lesion visible in CT and MR

3. Pain located in area of the lesion

4. Informed consent for participation in the study and for radiotherapy in interested area

Exclusion Criteria:

1. Any previous radiotherapy in region of treated hemangioma

2. Spinal damage or disease that may be associated with an increased radiosensitivity

3. The coexistence of the vertebral morphological changes at the level of hemangioma causing pressure on the nerve roots and / or spinal cord causing pain located in that area

4. Neurological deficits caused by the presence of hemangioma (patients should be considered for surgery)

5. Contradictions for MRI

6. Lack of informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemangioma
• Hemangioma of Vertebral Column

Intervention

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
• 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)

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch	Gliwice	Wybrzeze AK 15

Sponsors (1)

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

Country where clinical trial is conducted

Poland, 

References & Publications (16)

Asthana AK, Tandon SC, Pant GC, Srivastava A, Pradhan S. Radiation therapy for symptomatic vertebral haemangioma. Clin Oncol (R Coll Radiol). 1990 May;2(3):159-62. — View Citation

BARTKOWIAK E, BEDNARCZYK J. [CAVERNOUS ANGIOMA OF THE SPINE COMPLICATED BY COMPRESSION VERTEBRAL FRACTURE]. Chir Narzadow Ruchu Ortop Pol. 1964;29:393-6. Polish. — View Citation

Brackrock S, Krüll A, Schwarz R, Alberti W. [Results of radiotherapy for vertebral hemangioma]. Strahlenther Onkol. 1999 Aug;175(8):405-8. German. — View Citation

Bremnes RM, Hauge HN, Sagsveen R. Radiotherapy in the treatment of symptomatic vertebral hemangiomas: technical case report. Neurosurgery. 1996 Nov;39(5):1054-8. Review. — View Citation

Faria SL, Schlupp WR, Chiminazzo H Jr. Radiotherapy in the treatment of vertebral hemangiomas. Int J Radiat Oncol Biol Phys. 1985 Feb;11(2):387-90. — View Citation

Gerszten PC, Ozhasoglu C, Burton SA, Vogel WJ, Atkins BA, Kalnicki S, Welch WC. CyberKnife frameless single-fraction stereotactic radiosurgery for benign tumors of the spine. Neurosurg Focus. 2003 May 15;14(5):e16. — View Citation

Heyd R, Seegenschmiedt MH, Rades D, Winkler C, Eich HT, Bruns F, Gosheger G, Willich N, Micke O; German Cooperative Group on Radiotherapy for Benign Diseases. Radiotherapy for symptomatic vertebral hemangiomas: results of a multicenter study and literature review. Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):217-25. doi: 10.1016/j.ijrobp.2009.04.055. Epub 2009 Aug 21. Review. — View Citation

Miszczyk L, Ficek K, Trela K, Spindel J. The efficacy of radiotherapy for vertebral hemangiomas. Neoplasma. 2001;48(1):82-4. — View Citation

Miszczyk L, Tukiendorf A. Radiotherapy of painful vertebral hemangiomas: the single center retrospective analysis of 137 cases. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):e173-80. doi: 10.1016/j.ijrobp.2011.04.028. Epub 2011 Jun 2. — View Citation

Pavlovitch JM, Nguyen JP, Djindjian M, Mazeron JJ, Piedbois P, Le Bourgeois JP. [Radiotherapy of vertebral hemangioma with neurologic complications]. Neurochirurgie. 1989;35(5):296-8, 305-8. French. — View Citation

Rades D, Bajrovic A, Alberti W, Rudat V. Is there a dose-effect relationship for the treatment of symptomatic vertebral hemangioma? Int J Radiat Oncol Biol Phys. 2003 Jan 1;55(1):178-81. — View Citation

Sahgal A, Chou D, Ames C, Ma L, Lamborn K, Huang K, Chuang C, Aiken A, Petti P, Weinstein P, Larson D. Image-guided robotic stereotactic body radiotherapy for benign spinal tumors: theUniversity of California San Francisco preliminary experience. Technol Cancer Res Treat. 2007 Dec;6(6):595-604. — View Citation

Sakata K, Hareyama M, Oouchi A, Sido M, Nagakura H, Tamakawa M, Akiba H, Morita K. Radiotherapy of vertebral hemangiomas. Acta Oncol. 1997;36(7):719-24. — View Citation

Schild SE, Buskirk SJ, Frick LM, Cupps RE. Radiotherapy for large symptomatic hemangiomas. Int J Radiat Oncol Biol Phys. 1991 Aug;21(3):729-35. — View Citation

Winkler C, Dornfeld S, Baumann M, Christen N, Herrmann T, Eberhardt HJ. [The efficacy of radiotherapy in vertebral hemangiomas]. Strahlenther Onkol. 1996 Dec;172(12):681-4. German. — View Citation

Yang ZY, Zhang LJ, Chen ZX, Hu HY. Hemangioma of the vertebral column. A report on twenty-three patients with special reference to functional recovery after radiation therapy. Acta Radiol Oncol. 1985 Mar-Apr;24(2):129-32. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgetic effect	rate of pain relief	2 years	No
Secondary	Identification of radiologic prognostic and predictal factors of response to external beam radiotherapy (radiosurgery compared to conventional)		2 years	No
Secondary	Identification of biochemical and physical prognostic factors of response to external beam radiotherapy (radiosurgery compared to conventional)		2 years	Yes