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Completed

NCT Number: NCT03455231

Short Course Radiotherapy in Complicated Bone Metastases Palliation

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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Key information

Conditions

Palliative Care Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short Course Radiotherapy

Radiation

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

Primary outcomes

  1. Maximum tolerated dose

    Time frame: 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 outcomes

  1. Acute toxicity

    Time frame: 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).

  2. Quality of life

    Time frame: 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).

  3. Pain relief

    Time frame: 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).

  4. Late toxicity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Short Course Accelerated Radiation Therapy (Sharon) in Complicated Bone Metastases Palliation

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2018
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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