An interventional study of Short course radiotherapy in Palliative Care, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-12.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
The radiotherapy is delivered over two days with accelerated hypo-fractionation
Radiation: Short course radiotherapy
An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with complicated bone metastases
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
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
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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IRCCS Azienda Ospedaliero-Universitaria di Bologna