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RF Ablation of Painful Metastases Involving Bone


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Cancer, Pain

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Trial Information

RF Ablation of Painful Metastases Involving Bone


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

J. William Charboneau, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000069180

NCT ID:

NCT00029029

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Pain
  • bone metastases
  • pain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Mayo Clinic Cancer CenterRochester, Minnesota  55905
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Northwestern Memorial HospitalChicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410