NCT02376322

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Santa Casa de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bone Metastases

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Hypofractionated radiotherapy regimen, 16 Gy in 2 fractions in complicated bone metastases in patients with poor performance status

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-07-30
• Completion: 2016-07-30
• First posted: 2015-03-03
• Last updated: 2017-10-06

Locations

4 sites across 3 countries: Brazil, Canada, Italy