Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases

NCT ID: NCT00029029

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-13
• Study Completion Date: 2002-10-24

Brief Summary

RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells and may help to relieve pain caused by bone metastases.

PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in relieving pain in patients who have bone metastases.

Detailed Description

OBJECTIVES:

• Determine the efficacy of radiofrequency ablation, in terms of pain relief at 4 weeks, in patients with painful bone metastases.
• Determine the safety of this regimen in these patients.
• Compare the change in pain interference with daily life and analgesic use at 4 weeks vs baseline in patients treated with this regimen.
• Determine the time to recurrence of worst pain in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive radiofrequency ablation (RFA) to targeted tumor(s) on day 0 (multiple tumors may receive ablation in multiple sessions). Patients who achieve a reduction in worst pain of at least 2 points within 4-8 weeks but experience recurring pain at the RFA site or are diagnosed with a new painful lesion within 4-24 weeks receive 1 additional treatment to the recurring or new site.

Pain (using the Brief Pain Inventory scale of 0-10), analgesic use, and quality of life are assessed at baseline, on day 1, weekly for 4 weeks, and then every 2 weeks for 20 weeks.

Patients are followed for 6 months beyond the last RFA treatment.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.

Conditions

Metastatic Cancer; Pain

Study Design

• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

pain therapy

Intervention Type: PROCEDURE

radiofrequency ablation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed bone metastases
• Pain refractory to non-opioid analgesic medication and radiotherapy OR
• Patient is considered a poor candidate for opioid analgesics or radiotherapy
• Initial worst pain score within the past 24 hours at least 4 on a scale of 0-10
• Tumors deemed accessible for radiofrequency ablation
• No evidence of impending fracture in weight-bearing bones (more than 50% loss of cortical bone)
• Tumors must be more than 1 cm from critical structures including:

• Spinal cord, brain, or other critical nerve structures
• Large abdominal vessel (e.g., aorta or inferior vena cava)
• Bowel or bladder

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• More than 2 months

Hematopoietic:

• Platelet count at least 75,000/mm3

Hepatic:

• INR less than 1.5

Renal:

• Not specified

Other:

• Not pregnant or nursing
• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 3 weeks since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 3 weeks since prior radiotherapy

Surgery:

• Not specified

Other:

• At least 3 days since prior aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs
• No concurrent anticoagulants

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J. William Charboneau, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

RITA-201-00

Identifier Type: -

Identifier Source: secondary_id

MAYO-IRB-O-1223-00

Identifier Type: -

Identifier Source: secondary_id

MDA-ID-01534

Identifier Type: -

Identifier Source: secondary_id

RITA-IDE-G000177

Identifier Type: -

Identifier Source: secondary_id

CDR0000069180

Identifier Type: -

Identifier Source: org_study_id