Short Course Radiotherapy in Complicated Bone Metastases Palliation

IRCCS Azienda Ospedaliero-Universitaria di Bologna45 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Palliative Care

Interventions

Short course radiotherapyRADIATION

An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with complicated bone metastases

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Maximum tolerated dose

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

Time frame: 1 year

Secondary Outcomes

Acute toxicity

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).

Time frame: 1 year

Quality of life

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).

Time frame: 1 year

Pain relief

Pain after the therapy is evaluated with the visual analogically scale (VAS scale). Values range from 0 (no pain) to 10 (worst possible pain).

Time frame: 1 year

Late toxicity

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

Time frame: 1 year

Data from ClinicalTrials.gov

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