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Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases

Phase 2
18 Years
75 Years
Open (Enrolling)
Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases



- Measure the efficacy of morphine sulfate at 8 weeks after radiofrequency ablation (RFA)
of bone metastases.


- Assess minimum and average pain and analyze use of morphine sulfate before and after

- Determine disease progression by CT scan of bone.

- Evaluate the percentage of relief associated with RFA, specifically patient
satisfaction, quality of life, anxiety, depression, and physical performance during

- Assess complications and side effects related to RFA and the evolution of possible side
effects associated with morphine sulfate therapy.

OUTLINE: This is a multicenter study.

Patients complete a pain questionnaire over 1 week before undergoing radiofrequency ablation
(RFA). Patients also complete questionnaires about pain, physical performance, quality of
life (QOL), and anxiety at baseline.

Bone metastases are removed by radiofrequency ablation (RFA). After surgery, patients
receive acetaminophen and patient-controlled analgesic (PCA) morphine sulfate. PCA morphine
sulfate continues with a dose increase of 50% bolus every 24 hours. Patients with maximum
pain less than or equal to that at inclusion receive standard morphine sulfate therapy

Data concerning the total dose of PCA morphine sulfate; minimum, average, and maximum pain
intensity; side effects and complications of RFA; and total dose of morphine sulfate (or
equivalent) is collected daily.

Pain is assessed at 4 and 8 weeks after RFA. Patients complete follow-up questionnaires
about physical performance, QOL, and anxiety at 12 weeks. Patients also undergo a CT scan at
12 weeks.

Inclusion Criteria


- Histologically confirmed cancer

- Primary or unknown origin

- Painful bone metastases despite radiotherapy or symptomatic relapse into previously
irradiated area with no possibility of repeating radiotherapy

- Bone metastases may have been treated with bisphosphonates

- Osteolytic bone or joint (lytic and condensed) confirmed by CT scan and meeting
the following criteria:

- Lesion size ≤ 5 cm

- No more than 2 painful bone metastases

- If 2 lesions are to be treated, distinct anatomical locations can be
treated at the same time

- Metastatic bone lesions of the pelvis, sacrum (in absence of canal
involvement), ribs, or long bones allowed

- Pain located at the tumor or in the area

- Maximum pain in the last 24 hours > 4 points (numerical scale to 11 points)


- Life expectancy > 3 months

- Platelet count > 50,000/μL

- Prothrombin < 50%

- Activated cephalin time ≤ 1.5 times normal

- Not pregnant

- Fertile patients must use effective contraception

- No geographical, social, or psychiatric reason that would preclude follow up


- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- At least 3 weeks since prior chemotherapy or bisphosphonates

- At least 1 week since beginning new painkiller therapy or anticoagulation treatment

- More than 30 days since participation in another drug study

- More than 30 days since prior surgery

Type of Study:


Study Design:

Allocation: Non-Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Maximum pain level decreased by ≥ 2 points at 8 weeks after radiofrequency ablation (RFA)

Safety Issue:


Principal Investigator

Florence Dixmerias, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Bergonié



Study ID:




Start Date:

October 2007

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • bone metastases
  • unspecified adult solid tumor, protocol specific
  • pain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases