Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases

NCT01461252 | Withdrawn Phase 1

• 1 other identifier: CUC10-BNE01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the safety and efficacy of cryoablation therapy combined with radiation therapy for the relief of pain associated with metastatic bone tumors.

Conditions

Pain; Neoplasm Metastasis

Keywords

Painful bone metastases; Bone metastases; Metastatic bone tumors; Metastatic bone pain; Cryoablation; Cryotherapy; Cryosurgery; Radiation therapy; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Difference in worst pain scores

  The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation combined with radiation associated with palliation of pain in subjects with metastatic bone cancer by measuring the average difference of pre- and posttreatment worst pain in 24 hours from baseline to 24 hour, 1, 4, 12, and 24 week follow-up intervals as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale.

  24 weeks post cryoablation

Secondary Outcomes (8)

• Cryoablation retreatments

  24 weeks post-cryoablation

• Additional surgical treatments other than cryoablation

  24 weeks post-cryoablation

• Reduced analgesic usage

  24 weeks post-cryoablation

• Time to maximal palliation of pain after cryoablation

  24 weeks post-cryoablation

• Number of adverse events

  30 days post-cryoablation

Study Arms (1)

Cryoablation combined with radiation

OTHER

All subjects will have cryoablation combined with radiation on one or two painful metastatic bone tumors.

Procedure: Cryoablation; Procedure: Radiation

Interventions

Cryoablation PROCEDURE

For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator.

Also known as: Cryotherapy, Cryosurgery, Visual-ICE Cryoabltaion System, SeedNet Cryoablation System, PresIce Cryoablation System, IceRod Cryoablation Needle, IceRod PLUS Cryoablation Needle, IceEDGE 2.4 Cryoablation Needle, IceSeed Cryoablation Needle, IceSphere Cryoablation Needle

Cryoablation combined with radiation

Radiation PROCEDURE

Radiation therapy is usually performed with 6-18 Megavolt photons from a linear accelerator. The proposed dose and frequency of radiation for this protocol are: 8 Gray in 1 fraction, 30 Gray in 10 fractions, or 37.5 Gray in 15 fractions. These proposed doses or other doses will be prescribed at the discretion of the investigator. It is anticipated that subjects will begin the radiation therapy approximately within one to three weeks after the cryoablation procedure. The doses and frequency of the radiation treatment will be collected as well as toxicities.

Also known as: Radiotherapy

Cryoablation combined with radiation

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Metastatic bone disease with metastatic disease previously confirmed by prior biopsy; or Metastatic bone disease previously confirmed on imaging \[e.g. computed tomography (CT) or magnetic resonance imaging (MRI)\] with known (biopsied) primary disease (primary bone cancer is excluded)
• Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
• Unremitting pain that resulted in a return visit to the oncologist. The 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite pharmaceutical pain management
• Pain must be from one or two painful metastatic sites in the bone that is amenable to cryoablation with CT or MRI (additional less painful metastatic sites may be present)
• Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, MRI, or ultrasound (US) imaging
• Tumors must be suitable for cryoablation
• If the primary tumor is in the spine, there must be an intact cortex between the mass and the spinal canal and exiting nerve roots
• Cryoablation should be performed within 14 days of baseline evaluations
• Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
• Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)
• ECOG (Eastern Cooperative Oncology Group) scale performance status 0-3
• Life expectancy ≥ 2 months
• Platelet count \>50,000/mm³ within 6 weeks of screening
• INR (International Normalized Ratio) \<1.5 within 6 weeks of screening

You may not qualify if:

• Leukemia, lymphoma, and myeloma
• Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing \> 50% loss of cortical bone
• Has undergone prior ablation treatment of the index tumor
• Has undergone prior radiation therapy of the index tumor \< 3 weeks prior to screening
• Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
• Anticipated treatment of the index tumor that would require iceball formation within 1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava, bowel, or bladder
• Surgery at the tumor site or surgery involving the cryoablation-treated tumor
• Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
• ANC (absolute neutrophil count) \<1000 mm3 within 6 weeks of screening
• Uncontrolled coagulopathy or bleeding disorders
• Currently pregnant, nursing, or wishing to become pregnant during the study
• Active, uncontrolled infection
• Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to study entry
• Concurrent participation in other experimental studies that could affect the primary endpoint

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Related Publications (13)

• Callstrom MR, Charboneau JW. Image-guided palliation of painful metastases using percutaneous ablation. Tech Vasc Interv Radiol. 2007 Jun;10(2):120-31. doi: 10.1053/j.tvir.2007.09.003.

  PMID: 18070690 BACKGROUND

• McQuay HJ, Collins SL, Carroll D, Moore RA. Radiotherapy for the palliation of painful bone metastases. Cochrane Database Syst Rev. 2000;(2):CD001793. doi: 10.1002/14651858.CD001793.

  PMID: 10796822 BACKGROUND

• Chow E, Harris K, Fan G, Tsao M, Sze WM. Palliative radiotherapy trials for bone metastases: a systematic review. J Clin Oncol. 2007 Apr 10;25(11):1423-36. doi: 10.1200/JCO.2006.09.5281.

  PMID: 17416863 BACKGROUND

• Fairchild A, Barnes E, Ghosh S, Ben-Josef E, Roos D, Hartsell W, Holt T, Wu J, Janjan N, Chow E. International patterns of practice in palliative radiotherapy for painful bone metastases: evidence-based practice? Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1501-10. doi: 10.1016/j.ijrobp.2008.12.084. Epub 2009 May 21.

  PMID: 19464820 BACKGROUND

• Callstrom MR, Atwell TD, Charboneau JW, Farrell MA, Goetz MP, Rubin J, Sloan JA, Novotny PJ, Welch TJ, Maus TP, Wong GY, Brown KJ. Painful metastases involving bone: percutaneous image-guided cryoablation--prospective trial interim analysis. Radiology. 2006 Nov;241(2):572-80. doi: 10.1148/radiol.2412051247.

  PMID: 17057075 BACKGROUND

• Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. doi: 10.1634/theoncologist.5-6-463.

  PMID: 11110597 BACKGROUND

• Belfiore G, Tedeschi E, Ronza FM, Belfiore MP, Della Volpe T, Zeppetella G, Rotondo A. Radiofrequency ablation of bone metastases induces long-lasting palliation in patients with untreatable cancer. Singapore Med J. 2008 Jul;49(7):565-70.

  PMID: 18695866 BACKGROUND

• Simon CJ, Dupuy DE. Percutaneous minimally invasive therapies in the treatment of bone tumors: thermal ablation. Semin Musculoskelet Radiol. 2006 Jun;10(2):137-44. doi: 10.1055/s-2006-939031. Epub 2006 Apr 5.

  PMID: 16598666 BACKGROUND

• Ullrick SR, Hebert JJ, Davis KW. Cryoablation in the musculoskeletal system. Curr Probl Diagn Radiol. 2008 Jan-Feb;37(1):39-48. doi: 10.1067/j.cpradiol.2007.05.001.

  PMID: 18054665 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

• Wu JS, Wong R, Johnston M, Bezjak A, Whelan T; Cancer Care Ontario Practice Guidelines Initiative Supportive Care Group. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):594-605. doi: 10.1016/s0360-3016(02)04147-0.

  PMID: 12573746 BACKGROUND

• Dupuy DE, Liu D, Hartfeil D, Hanna L, Blume JD, Ahrar K, Lopez R, Safran H, DiPetrillo T. Percutaneous radiofrequency ablation of painful osseous metastases: a multicenter American College of Radiology Imaging Network trial. Cancer. 2010 Feb 15;116(4):989-97. doi: 10.1002/cncr.24837.

  PMID: 20041484 BACKGROUND

• Callstrom MR, York JD, Gaba RC, Gemmete JJ, Gervais DA, Millward SF, Brown DB, Dupuy D, Goldberg SN, Kundu S, Rose SC, Thomas JJ, Cardella JF; Technology Assessment Committee of Society of Interventional Radiology. Research reporting standards for image-guided ablation of bone and soft tissue tumors. J Vasc Interv Radiol. 2009 Dec;20(12):1527-40. doi: 10.1016/j.jvir.2009.08.009. Epub 2009 Oct 27. No abstract available.

  PMID: 19864161 BACKGROUND

MeSH Terms

Conditions

Pain; Neoplasm Metastasis; Bone Neoplasms

Interventions

Cryosurgery; Cryotherapy; Radiation; Radiotherapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Pathologic Processes; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Therapeutics; Physical Phenomena

Study Officials

• Jerry Matteo, MD

  Shands Medical Center, Jacksonville, FL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 28, 2011
• Study Start: April 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 16, 2021

Record last verified: 2021-07