Short Course Radiotherapy in Complicated Bone Metastases Palliation

Not Applicable

Completed

• Conditions: Palliative Care
• Interventions: Radiation: Short course radiotherapy

• Registration Number: NCT03455231
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with complicated bone metastases.

Detailed Description

The study wants to define the maximum tolerated dose (MTD) of a conformal short course radiation treatment delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of complicated bone metastases.

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Study First Submitted: 2018-02-26
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-06
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• radiologically proven complicated bone metastasis
• age > 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status < 3

Exclusion Criteria

• prior RT to the same region

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Short course radiotherapy	Short course radiotherapy	The radiotherapy is delivered over two days with accelerated hypo-fractionation

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	1 year	The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients

Secondary Outcome Measures

Name	Time	Method
Quality of life	1 year	Quality of life after treatment is evaluated according to Cancer Lineal Analog Scale (CLAS) which evaluated well-being, fatigue, and ability to perform daily activities (values range from 0 that represents the best status to 10 that represents the worst one).
Pain relief	1 year	Pain after the therapy is evaluated with the visual analogically scale (VAS scale). Values range from 0 (no pain) to 10 (worst possible pain).
Acute toxicity	1 year	Acute toxicity after treatment is evaluated with Common Terminology Criteria for Adverse Events (CTCAE) scale (values from 1 that represents the minimum acute toxicity to 5 that represent the maximum/severe acute toxicity).
Late toxicity	1 year	Late toxicity after treatment is evaluated with Toxicity criteria of the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (EORTC-RTOG scale). The values range from 1 that represents the minimum late toxicity to 5 that represent the maximum/severe late toxicity