Short Course Radiotherapy in Complicated Bone Metastases Palliation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-01

Study Completion Date

2017-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Palliative Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Short course radiotherapy

The radiotherapy is delivered over two days with accelerated hypo-fractionation

Group Type EXPERIMENTAL

Short course radiotherapy

Intervention Type RADIATION

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

Interventions

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Short course radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Alessio Giuseppe Morganti

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessio G. Morganti, MD

Role: PRINCIPAL_INVESTIGATOR

Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy