Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases

NCT00608855 | Completed

• 2 other identifiers: MC03C3MAYO-MC03C3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

Brief Summary

RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases. PURPOSE: This clinical trial is studying the side effects and how well percutaneous cryoablation works in treating patients with painful bone metastases.

Conditions

Metastatic Cancer; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

bone metastases; pain; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8

Secondary Outcomes (3)

• Average difference in pre- and post-treatment worst pain score in a 24-hour period, average pain score, and pain relief score at 6, 12, and 24 months

• Average amount of pain per patient over the observation period as represented by the area under the curve (AUC) constructed from weekly pain scores on a visual-analogue scale using a score of 0-10

• Percentage of patients who are able to reduce analgesic medications

Interventions

questionnaire administration OTHER

cryosurgery PROCEDURE

pain therapy PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic solid tumor involving or abutting bone (index lesion) * If the nature of the metastatic disease has been previously documented, index lesion to be treated does not require further documentation (i.e., biopsy) * Pain either refractory to standard care (chemotherapy, radiotherapy, surgery, or analgesics) or patient is considered a poor candidate for conventional therapies * Radiation oncology consult is required if the patient is considered clinically to be a candidate for conventional palliative radiotherapy * Surgical oncology consult is required if the patient is considered clinically to be a candidate for conventional surgical treatment or is considered at risk for complications resulting from potential fracture * Initial pain score ≥ 4 on a scale of 0-10 for the question "Please rate your pain by circling the one number that best describes your pain at its worst in the past 24 hours" on the Cleeland Brief Pain Inventory * Pain from ≤ 2 sites of metastatic disease * No lesions with evidence for impending fracture involving a weight-bearing bone (\> 50% loss of cortical bone at the site) PATIENT CHARACTERISTICS: * Life expectancy ≥ 2 months * Platelet count ≥ 75,000/mm³ * ANC \> 1,500/mm³ (for patients who have recently been treated with chemotherapy) * INR ≤ 1.2 * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: * More than 3 weeks since prior radiotherapy * More than 3 weeks since initiation of a new chemotherapy regimen, including bisphosphonates * More than 7 days since prior antiplatelet medications or clopidogrel * More than 3 days since prior acetylsalicylic acid (aspirin), ibuprofen, or other NSAIDs * No prior treatment of the portion of a lesion within 0.5 cm of the spinal cord or brain, within 0.5 cm of a large abdominal vessel such as the aorta or inferior vena cava, or within 1 cm of bowel or bladder * No prior radiofrequency ablation for pain palliation of the same lesion * No concurrent regular or low molecular weight heparin or other anticoagulants

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Brown University School of Medicine

Providence, Rhode Island, 02912, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Pain

Interventions

Cryosurgery; Analgesia

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Anesthesia and Analgesia

Study Officials

• Matthew R. Callstrom, MD, PhD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 6, 2008
• Study Start: November 1, 2003
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

US (10)