Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer (NCT00712712) | Clinical Trial Compass
CompletedPhase 2
Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer
France78 participantsStarted 2007-12-24
Plain-language 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 radiofrequency ablation of painful bone metastases in patients with cancer.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)