Status:
COMPLETED
Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer
Lead Sponsor:
Institut Bergonié
Conditions:
Metastatic Cancer
Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Morphine may reduce pain in patients who have undergone radiofrequency ablation to remove bone metastases. PURPOSE: This phase II trial is studying how well morphine works after radiofrequ...
Detailed Description
OBJECTIVES: Primary * Measure the efficacy of morphine sulfate at 8 weeks after radiofrequency ablation (RFA) of bone metastases. Secondary * Assess minimum and average pain and analyze use of mor...
Eligibility Criteria
Inclusion
- 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)
- 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
- 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
Exclusion
Key Trial Info
Start Date :
December 24 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2016
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00712712
Start Date
December 24 2007
End Date
March 16 2016
Last Update
August 29 2025
Active Locations (1)
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1
Institute Bergonié
Bordeaux, France, 33076