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Compassionate Same-Day Evaluation & Delivery of XRT for Bony Metastasis in Hospice Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01760941
Recruitment Status : Terminated (Slow accrual)
First Posted : January 4, 2013
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Symptomatic Osseous Bone Lesions From Any Malignancy
Interventions Radiation: Radiation Therapy
Other: Quality-of-Life Assessment
Other: Survey Administration
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiotherapy
Hide Arm/Group Description

Single fraction radiotherapy

Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.

planning.

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Radiotherapy
Hide Arm/Group Description

Single fraction radiotherapy

Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.

planning.

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Feasibility of Treatment Delivery in the Same Day as Initial Evaluation
Hide Description Patient evaluation will consist of surveys conducted at the time of treatment measured by the Radiation Oncologist Evaluation and Feasibility Assessments survey
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiotherapy
Hide Arm/Group Description:

Single fraction radiotherapy

Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.

planning.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction
Hide Description Evaluate the treatment influence on the rate of pain stabilization and/or reduction as measured by the validated BPI patient questionnaire.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiotherapy
Hide Arm/Group Description:

Single fraction radiotherapy

Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.

planning.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Evaluate the Treatment Influence on Patient Quality of Life
Hide Description Evaluate the treatment influence on patient quality of life as measured by the ESAS.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiotherapy
Hide Arm/Group Description:

Single fraction radiotherapy

Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.

planning.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Other Pre-specified Outcome
Title Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile
Hide Description Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiotherapy
Hide Arm/Group Description:

Single fraction radiotherapy

Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.

planning.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description As this is a survey study and not a drug study, changed from an "Adverse Events" section to a "Study Risks" section. No AEs or SAEs were collected.
 
Arm/Group Title Radiotherapy
Hide Arm/Group Description

Single fraction radiotherapy

Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.

planning.

All-Cause Mortality
Radiotherapy
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Radiotherapy
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radiotherapy
Affected / at Risk (%)
Total   0/0 
No data analysis or outcome measures for one participant enrolled and zero participants analyzed. Early suspension and termination due to slow accrual from Protocol Review and Monitoring Committee.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Drew Moghanaki, MD, MPH
Organization: Virginia Commonwealth University/Massey Cancer Center
Phone: 804-765-5850
EMail: Drew.moghanaki@vcuhealth.org
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01760941    
Other Study ID Numbers: MCC-14596
NCI-2012-03117 ( Registry Identifier: NCI CTRP )
First Submitted: December 20, 2012
First Posted: January 4, 2013
Results First Submitted: December 18, 2015
Results First Posted: February 29, 2016
Last Update Posted: February 29, 2016