Clinical trial · Interventional
Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer
Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases
NCT00712712CI-TRIAL-00094264MEDORcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 radiofrequency ablation of painful bone metastases in patients with cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Pain | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen | Drug | — | UNRESOLVED |
| Morphine Sulfate | Drug | — | UNRESOLVED |
| Quality-of-life assessment | Procedure | — | UNRESOLVED |
| Questionnaire administration | Other | — | UNRESOLVED |
| Radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient who has undergone radiofrequency ablation of bone metastases
- description
- Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
- interventionNames
- Drug: Acetaminophen
- Drug: Morphine Sulfate
- Other: Questionnaire administration
- Procedure: Quality-of-life assessment
- Procedure: Radiofrequency ablation
Primary outcomes (1)
- measure
- Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA)
- timeFrame
- 2 months after radiofrequency ablation (RFA)
- description
- Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to an 11-point numerical scale Rate of patients with a decrease of two or more points in their most intense pain, 2 months after the radiofrequency ablation. This rate is calculated for the evaluable population for the principal outcome measure. This rate is equal to the ratio of the number of patients with a decrease of two or more points in their maximum pain divided by the size of the evaluable population. The response rate considered acceptable is 50%, above this threshold the treatment will be considered potentially effective and may be proposed in phase III.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 surgeryReferences
Publications (0)
Data not yet available
No reference posted for this study.