NCT03455231

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2018

Enrollment Period

8 years

First QC Date

February 26, 2018

Last Update Submit

March 8, 2018

Conditions

Palliative Care

Keywords

palliative carecomplicated bone metastasesradiotherapypainquality of life

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (4)

  • Acute toxicity

    1 year

  • Quality of life

    1 year

  • Pain relief

    1 year

  • Late toxicity

    1 year

Study Arms (1)

Short course radiotherapy

EXPERIMENTAL

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

Radiation: Short course radiotherapy

Interventions

Short course radiotherapyRADIATION

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

Short course radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • prior RT to the same region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Capuccini J, Macchia G, Farina E, Buwenge M, Genovesi D, Caravatta L, Nguyen NP, Cammelli S, Cilla S, Wondemagegnhu T, Uddin AFMK, Aziz Sumon M, Cellini F, Valentini V, Deodato F, Morganti AG. Short-course regimen of palliative radiotherapy in complicated bone metastases: a phase i-ii study (SHARON Project). Clin Exp Metastasis. 2018 Oct;35(7):605-611. doi: 10.1007/s10585-018-9931-9. Epub 2018 Aug 18.

    PMID: 30121938DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alessio G. Morganti, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 6, 2018

Study Start

January 1, 2009

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 12, 2018

Record last verified: 2018-03