Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Active	18 to 75	Other	IB-MEDOR 2007-16, IB-2007-16, INCA-RECF0498, EUDRACT-2007-002686-13, NCT00712712

Objectives

Primary

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

Secondary

1. Assess minimum and average pain and analyze use of morphine sulfate before and after RFA.
2. Determine disease progression by CT scan of bone.
3. Evaluate the percentage of relief associated with RFA, specifically patient satisfaction, quality of life, anxiety, depression, and physical performance during RFA.
4. Assess complications and side effects related to RFA and the evolution of possible side effects associated with morphine sulfate therapy.

Entry Criteria

Disease Characteristics:

• 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)

Prior/Concurrent Therapy:

• 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

Patient Characteristics:

• 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

Expected Enrollment

Outcomes

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

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 instead.

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.

Trial Contact Information

Trial Lead Organizations

Institut Bergonie

Florence Dixmerias, MD, Protocol chair		Ph: 33-556-333-264

France
	Bordeaux
	Institut Bergonie
		Contact Person	Ph:  33-556-333-333
			Email: dixmerias@bergonie.org

Registry Information
Official Title		Evaluation of the effectiveness of the radiofrequency ablation for reducing refractory pain from bone metastases
Trial Start Date		2007-10-22
Trial Completion Date		2008-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00712712
Date Submitted to PDQ		2008-03-10
Information Last Verified		2008-12-28