Aim of the study is to assess efficacy of a short course radiation treatment in patients with complicated bone metastases
Standard treatment for complicated bone metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (4000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
3000 cGy in 10 daily fractions
2000 cGy in 4 fractions administered twice a day
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
Bologna, BO, Italy
RECRUITINGEfficacy of palliation using the short course scheme compared with the standard scheme
Reduction of pain after radiotherapy, assessed with VAS (visual analogue scale)
Time frame: 3 months
Acute toxicity in the two treatment groups
incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria
Time frame: 3 months
Late toxicity in the two treatment groups
incidence of treatment-related late adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbidity Scoring Schema
Time frame: 12 months
Quality of Life (QoL) assessment in the two groups
Changes in QoL after the treatment assessed using EORTC questionnaires (QLQ-BM22 and C15-PAL)
Time frame: 12 months
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