Status:
COMPLETED
Palliative Radiotherapy for Bone Metastases: Single Versus Multiple Fractions.
Lead Sponsor:
Marilia Medicine School
Conditions:
Bone Metastases
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of the investigators study was to determine whether 8 Gy in a single fraction provides equivalent pain and narcotic relief compared to 30 Gy in 10 fractions for patients with painful bone meta...
Detailed Description
This prospective, phase III, randomized study was conducted by department of radiation oncology at Marilia Medicine School, São Paulo, Brazil. Eligibility requirements included: Age of 18 years or o...
Eligibility Criteria
Inclusion
- Age of 18 years or older, histologically proven primary malignancy of any histological type, radiographic evidence of bone metastasis, pain corresponding to the area of bone metastasis, a Karnofsky performance status of at least 40, and an estimated life expectancy of at least 1 month.
- Histologic diagnosis was established from needle biopsy, bone marrow biopsy, cytology, or a surgical biopsy or resection. Radiographic evidence of bone metastasis was required and performed within 8 weeks prior to randomization.
Exclusion
- The patient was ineligible if the systemic agent commences within the 30 days prior to registration.
- This includes hormonal therapy, chemotherapy, and immunotherapy.
- Patients were ineligible if the painful area had received prior radiation therapy or palliative surgery, if there was pathologic fracture or impending fracture of the treatment site, or if there was planned surgical fi xation of the bone.
- Patients with clinical or radiographic evidence of spinal cord or cauda equina compression and/or effacement were not eligible.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00858741
Last Update
March 10 2009
Active Locations (1)
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1
Radiation Oncology Department at Marilia Medicine school
Marília, São Paulo, Brazil, 17501570