Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases - Full Text View

Purpose

The primary objective is to evaluate the tolerability (side effects) of the intraoperative radio therapy (IORT) (e.g., wound healing, infections, bone necrosis, nerve, spinal cord damage, and pathological fracture), and the secondary objective is to evaluate the effectiveness of IORT (i.e., pain relief, quality of life, narcotic use, and tumor response).

Condition	Intervention	Phase
Spinal Metastasis	Radiation: IORT with Kyphoplasty Device: Intrabeam®	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases

Further study details as provided by Abhishek Solanki, Loyola University:

Primary Outcome Measures:

Pain [ Time Frame: 52 weeks ]
Patient will rate the severity of pain on a numeric 0-10 scale with higher scores indicating more severe pain. Pain assessment will be done at baseline, day of the procedure, and during follow up visits for up to 52 weeks.

Secondary Outcome Measures:

Tumor Response [ Time Frame: 52 weeks ]
Patients will be classified at week 52 as having (1) disappearance of the treated lesion (i.e., complete response), (2) at least 30% decrease in the diameter of the treated lesion (i.e., partial response), (3) at least 20% increase in the diameter of the treated lesion (i.e., progressive disease), or (4) Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease (i.e., stable disease).


Estimated Enrollment:	10
Study Start Date:	December 2014
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Combined IORT and Kyphoplasty IORT with Kyphoplasty	Radiation: IORT with Kyphoplasty IORT with kyphoplasty is give concurrently for the treatment of spinal metastases Device: Intrabeam®

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Eligibility


Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Metastatic patients from solid tumor
Estimated life expectancy of at least 3 months
Age >= 50 years.
Karnofsky Performance Status >= 70%
Numeric Pain Intensity Score >= 3
10% or more loss of vertebrae height
Adequate organ and marrow function as defined below:
International normalized ratio (INR)/ prothrombin time (PT) within normal institutional limits
leukocytes >= 3,000 microliter (mcL)
Absolute neutrophil count >= 1,500 mcL
Platelets >= 100,000 mcl
Total bilirubin within normal institutional limits
Abnormal aspartate transaminase (AST or SGOT) or alanine transaminase (ALT or SPGT)
Abnormal creatinine
Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

Patients who have had prior external beam radiotherapy or surgery in the area of planned intervention
Previous radiopharmaceuticals (i.e, Ra-222, Sr-90, etc) within 30 days of procedure
Patients who are receiving systemic therapy (chemotherapy, hormonal, immunotherapy, bisphosphonates, etc) or other investigational agents are eligible if the systemic therapy can be safely held two weeks prior to procedure. These therapies may be resumed two weeks after the procedure
Primary hematologic malignancies
Patients with clinical or radiographic evidence of spinal cord or cauda equine compression or effacement
Chronic vertebrae fracture of greater than 6 months or coexisting bilateral pedicle fracture
Previous kyphoplasty in the same area
Patients with severe spinal deformity requiring open reconstruction or extreme adiposity, in which determining placement of metal sleeve would be difficult by fluoroscopy (limited bone margin)
History of allergic reactions attributed to compounds of similar composition to agents used for kyphoplasty
Uncontrolled medical illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pre-menopausal female

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02480036

Contacts


Contact: Beth Chiappetta, BSN	708-216-2568	bchiappetta@lumc.edu

Locations


United States, Illinois
Loyola University Medical Center	Recruiting
Maywood, Illinois, United States, 60153
Contact: Beth Chiappetta, BSN 708-216-2568 bchiappetta@lumc.edu
Principal Investigator: William Small, MD

Sponsors and Collaborators

Loyola University

Investigators


Principal Investigator:	William Small, MD	Loyola University

More Information

Publications:

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Ben-Josef E, Shamsa F, Williams AO, Porter AT. Radiotherapeutic management of osseous metastases: a survey of current patterns of care. Int J Radiat Oncol Biol Phys. 1998 Mar 1;40(4):915-21.

Coleman RE. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev. 2001 Jun;27(3):165-76. Review.

Eck JC, Nachtigall D, Humphreys SC, Hodges SD. Comparison of vertebroplasty and balloon kyphoplasty for treatment of vertebral compression fractures: a meta-analysis of the literature. Spine J. 2008 May-Jun;8(3):488-97. Epub 2007 May 29.

Fourney DR, Schomer DF, Nader R, Chlan-Fourney J, Suki D, Ahrar K, Rhines LD, Gokaslan ZL. Percutaneous vertebroplasty and kyphoplasty for painful vertebral body fractures in cancer patients. J Neurosurg. 2003 Jan;98(1 Suppl):21-30.

Hage WD, Aboulafia AJ, Aboulafia DM. Incidence, location, and diagnostic evaluation of metastatic bone disease. Orthop Clin North Am. 2000 Oct;31(4):515-28, vii. Review.

Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804.

Janjan NA. Radiation for bone metastases: conventional techniques and the role of systemic radiopharmaceuticals. Cancer. 1997 Oct 15;80(8 Suppl):1628-45. Review.

Kraus-Tiefenbacher U, Steil V, Bauer L, Melchert F, Wenz F. A novel mobile device for intraoperative radiotherapy (IORT). Onkologie. 2003 Dec;26(6):596-8.

Krishnan MS, Epstein-Peterson Z, Chen YH, Tseng YD, Wright AA, Temel JS, Catalano P, Balboni TA. Predicting life expectancy in patients with metastatic cancer receiving palliative radiotherapy: the TEACHH model. Cancer. 2014 Jan 1;120(1):134-41. doi: 10.1002/cncr.28408. Epub 2013 Oct 2.

Li S, Peng Y, Weinhandl ED, Blaes AH, Cetin K, Chia VM, Stryker S, Pinzone JJ, Acquavella JF, Arneson TJ. Estimated number of prevalent cases of metastatic bone disease in the US adult population. Clin Epidemiol. 2012;4:87-93. doi: 10.2147/CLEP.S28339. Epub 2012 Apr 10.

Maranzano E, Latini P. Effectiveness of radiation therapy without surgery in metastatic spinal cord compression: final results from a prospective trial. Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):959-67.

McCall T, Cole C, Dailey A. Vertebroplasty and kyphoplasty: a comparative review of efficacy and adverse events. Curr Rev Musculoskelet Med. 2008 Mar;1(1):17-23. doi: 10.1007/s12178-007-9013-0.

Reis T, Schneider F, Welzel G, Schmidt R, Bludau F, Obertacke U, Wenz F. Intraoperative radiotherapy during kyphoplasty for vertebral metastases (Kypho-IORT): first clinical results. Tumori. 2012 Jul-Aug;98(4):434-40. doi: 10.1700/1146.12636.

Rose PS, Laufer I, Boland PJ, Hanover A, Bilsky MH, Yamada J, Lis E. Risk of fracture after single fraction image-guided intensity-modulated radiation therapy to spinal metastases. J Clin Oncol. 2009 Oct 20;27(30):5075-9. doi: 10.1200/JCO.2008.19.3508. Epub 2009 Sep 8.

Schneider F, Greineck F, Clausen S, Mai S, Obertacke U, Reis T, Wenz F. Development of a novel method for intraoperative radiotherapy during kyphoplasty for spinal metastases (Kypho-IORT). Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):1114-9. doi: 10.1016/j.ijrobp.2010.07.1985. Epub 2010 Oct 8.

Wenz F, Schneider F, Neumaier C, Kraus-Tiefenbacher U, Reis T, Schmidt R, Obertacke U. Kypho-IORT--a novel approach of intraoperative radiotherapy during kyphoplasty for vertebral metastases. Radiat Oncol. 2010 Feb 11;5:11. doi: 10.1186/1748-717X-5-11.

Willett CG, Czito BG, Tyler DS. Intraoperative radiation therapy. J Clin Oncol. 2007 Mar 10;25(8):971-7. Review.

Wong DA, Fornasier VL, MacNab I. Spinal metastases: the obvious, the occult, and the impostors. Spine (Phila Pa 1976). 1990 Jan;15(1):1-4.


Responsible Party:	Abhishek Solanki, Assistant Professor, Loyola University
ClinicalTrials.gov Identifier:	NCT02480036 History of Changes
Other Study ID Numbers:	206824 206824091714 ( Other Identifier: Loyola University Chicago )
Study First Received:	June 10, 2015
Last Updated:	November 14, 2016

Keywords provided by Abhishek Solanki, Loyola University:


IORT Kyphoplasty Spine Cancer

Additional relevant MeSH terms:


Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes

ClinicalTrials.gov processed this record on June 26, 2017

Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases (KYPHO-IORT)