Combining Intraoperative Radiotherapy With Kyphoplasty for Treatment of Spinal Metastases

NCT02480036 | Unknown Phase 1 DMC

• 2 other identifiers: 206824206824091714
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Spinal Metastasis

Keywords

IORT; Kyphoplasty; Spine; Cancer

Outcome Measures

Primary Outcomes (1)

• Pain

  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.

  52 weeks

Secondary Outcomes (1)

• Tumor Response

  52 weeks

Study Arms (1)

Combined IORT and Kyphoplasty

EXPERIMENTAL

IORT with Kyphoplasty IORT Device: Intrabeam®

Radiation: IORT with Kyphoplasty; Device: Intrabeam®

Interventions

IORT with Kyphoplasty RADIATION

IORT with kyphoplasty is give concurrently for the treatment of spinal metastases

Combined IORT and Kyphoplasty

Intrabeam® DEVICE

Combined IORT and Kyphoplasty

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Related Publications (19)

• Bartels RH, van der Linden YM, van der Graaf WT. Spinal extradural metastasis: review of current treatment options. CA Cancer J Clin. 2008 Jul-Aug;58(4):245-59. doi: 10.3322/CA.2007.0016. Epub 2008 Mar 19.

  PMID: 18354080 BACKGROUND

• 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. doi: 10.1016/s0360-3016(97)00927-9.

  PMID: 9531377 BACKGROUND

• Coleman RE. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev. 2001 Jun;27(3):165-76. doi: 10.1053/ctrv.2000.0210.

  PMID: 11417967 BACKGROUND

• 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. doi: 10.1016/j.spinee.2007.04.004. Epub 2007 May 29.

  PMID: 17588820 BACKGROUND

• 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. doi: 10.3171/spi.2003.98.1.0021.

  PMID: 12546384 BACKGROUND

• 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. doi: 10.1016/s0030-5898(05)70171-1.

  PMID: 11043092 BACKGROUND

• 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. doi: 10.1093/jnci/dji139.

  PMID: 15928300 BACKGROUND

• Janjan NA. Radiation for bone metastases: conventional techniques and the role of systemic radiopharmaceuticals. Cancer. 1997 Oct 15;80(8 Suppl):1628-45. doi: 10.1002/(sici)1097-0142(19971015)80:8+3.3.co;2-l.

  PMID: 9362430 BACKGROUND

• 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. doi: 10.1159/000074158. No abstract available.

  PMID: 14709937 BACKGROUND

• 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.

  PMID: 24122413 BACKGROUND

• 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.

  PMID: 22570568 BACKGROUND

• 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. doi: 10.1016/0360-3016(95)00572-g.

  PMID: 7607970 BACKGROUND

• 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.

  PMID: 19468894 BACKGROUND

• 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: 10.1177/030089161209800406.

  PMID: 23052158 BACKGROUND

• 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.

  PMID: 19738130 BACKGROUND

• 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.

  PMID: 20934272 BACKGROUND

• 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.

  PMID: 20149237 BACKGROUND

• Willett CG, Czito BG, Tyler DS. Intraoperative radiation therapy. J Clin Oncol. 2007 Mar 10;25(8):971-7. doi: 10.1200/JCO.2006.10.0255.

  PMID: 17350946 BACKGROUND

• 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.

  PMID: 2326692 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Kyphoplasty

Intervention Hierarchy (Ancestors)

Vertebroplasty; Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• William Small, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Chiappetta, BSN

CONTACT

708-216-2568; bchiappetta@lumc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 24, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 7, 2020

Record last verified: 2020-09

Locations

US (1)