Literature has shown that hypofractionated radiotherapy regimens are efficacious in patients with complicated bone metastases and have a low potential for severe treatment-related toxicities. There is a clear need for hypofractionated schedules in the complicated bone metastases population, especially when considering the overarching aim of palliative radiotherapy and the clinical features of this patient population. As well, current research examining hypofractionated approaches in bone metastases patients with impending or pathologic fractures, neuropathic pain or accompanying soft tissue masses has been markedly scarce.
In response the the already commented on, the purpose of this one armed, phase II trial is to determine the efficacy and safety profile of a hypofractionated radiotherapy regimen, 16 Gy in 2 fractions with an interval of one week, for the palliation of complicated bone metastases in patients with poor performance status.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Hypofractionated radiotherapy regimen, 16 Gy in 2 fractions in complicated bone metastases in patients with poor performance status
ISCMPA
Porto Alegre, Rio Grande do Sul, Brazil
ICESP
São Paulo, São Paulo, Brazil
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
S. Maria Hospital
Terni, Italy
Overall pain response at the site of treatment, which will be measured at two months post-treatment. Pain response will be measured using the International Consensus on Palliative Radiotherapy Endpoints Pain Response Categories.
The general follow up will finish 1 year after each patient inclusion
Time frame: 2 months after the end of the second radiotherapy fraction
Quality of life as assessed by the EORTC QLQ PAL-15 and EORTC QLQ-BM22
Quality of life assessed by these 2 questionnaries will follow composite information
Time frame: General follow up will be 1 year after each patient inclusion
Side effects of Radiotherapy.
Nausea and vomiting, pain flare, skin rash, esophagitis, mucositis, diarrhea, spinal cord/cauda equina compression, pathologic fracture, re-irradiation rate).
Time frame: General follow up will be 1 year after each patient inclusion
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