Hypofractionated Radiation Therapy (16/2) for the Palliation of Complicated Bone Metastases in Patients With KPS

Official Title

A Phase II Trial of Hypofractionated Radiation Therapy (16 Gy in 2 Fractions With an Interval of One Week) for the Palliation of Complicated Bone Metastases in Patients With Poor Performance Status


Literature has shown that hypofractionated radiation therapy 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 radiation therapy 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.

Trial Description

Primary Outcome:

  • 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 Radiation Therapy Endpoints Pain Response Categories.
Secondary Outcome:
  • Quality of life as assessed by the EORTC QLQ PAL-15 and EORTC QLQ-BM22
  • Side effects of Radiation Therapy.
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 radiation therapy 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.

View this trial on ClinicalTrials.gov

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