Status:
COMPLETED
Optimization of Radiotherapy in Treatment of Painful Bone Metastasis
Lead Sponsor:
International Atomic Energy Agency
Conditions:
Pain
Bone Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Bone metastasis is one of the most frequent end complications of the cancer. Radiation therapy is the mainstay of treatment in this disease. Single fraction radiotherapy in both single and multiple bo...
Detailed Description
PROTOCOL SCHEMA Group A Treatment of single site of painful bone metastasis: Arm 1: 4 Gy single fraction; mandate first retreatment if moderate or severe pain persists or recurs (as measured by cate...
Eligibility Criteria
Inclusion
- histological diagnosis of malignancy associated with radiological evidence of painful bone metastasis
- If patients with two sites of pain requiring separate treatment are to be entered, the same randomized treatment option will be used for both sites, but response at each site will be scored and analyzed separately.
- age \> 18 years
- anticipated remaining life of at least 12 weeks (3 months)
- informed consent
Exclusion
- Primary histology myeloma
- Sites of previous RT or previous radioisotope treatment
- conditions or circumstances, which may interfere with treatment or follow-up
- complicated bone metastasis (pathological fractures, metastatic spinal cord compression)
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00610272
Start Date
January 1 2008
End Date
August 1 2012
Last Update
August 7 2013
Active Locations (12)
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1
Centre Pierre et Marie Curie, Centre hospitalier universitaire Mustapha (CHU)
Algiers, Algeria, 16016
2
Irmandade de Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil, 90020-090
3
Misr Oncology Center (MOC)
Cairo, Egypt
4
Tata Memorial Hospital
Mumbai, India, Maharashtra 400 012