Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis

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: NCT01525745
Recruitment Status : Terminated (Local IRB decision due to poor accrual)
First Posted : February 3, 2012
Results First Posted : August 29, 2016
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Anand Mahadevan, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Primary Tumor
Metastatic Cancer
Interventions Radiation: Radiosurgery/SBRT
Radiation: External Beam Radiation Therapy
Enrollment 6
Recruitment Details all participants were enrolled in the RadOnc clinic at BIDMC
Pre-assignment Details  
Arm/Group Title Radiosurgery/SBRT External Beam Radiation Therapy
Hide Arm/Group Description

Radiosurgery/SBRT

Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments

External Beam Radiation Therapy

External Beam Radiation Therapy: 10 consecutive days of standard radiation

Period Title: Overall Study
Started 4 2
Completed 3 1
Not Completed 1 1
Arm/Group Title A/Radiosurgery-SBRT B/External Beam Radiation Therapy Total
Hide Arm/Group Description Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments External Beam Radiation Therapy: 10 consecutive days of standard radiation Total of all reporting groups
Overall Number of Baseline Participants 4 2 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  50.0%
1
  50.0%
3
  50.0%
>=65 years
2
  50.0%
1
  50.0%
3
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
Female
2
  50.0%
1
  50.0%
3
  50.0%
Male
2
  50.0%
1
  50.0%
3
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 2 participants 6 participants
4 2 6
1.Primary Outcome
Title Pain Control as Measured by NPRS
Hide Description Determine if image-guided radiosurgery/SBRT improves pain control as measured by NPRS as compared to conventional external beam radiotherapy
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
study was terminated by the local IRB due to slow accrual. 1 participant withdrew consent and 1 participant did not complete the assigned arm treatment per protocol and then removed from study. left with 4 participants and data were not collected for any participants therefore no analysis has been done.
Arm/Group Title A/Radiosurgery-SBRT B/External Beam Radiation Therapy
Hide Arm/Group Description:
Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
External Beam Radiation Therapy: 10 consecutive days of standard radiation
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Duration of Pain Response
Hide Description Determine if image-guided radiosurgery/SBRT improves duration of pain as compared to conventional external beam radiotherapy
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
data not collected, therefore no analysis done
Arm/Group Title Radiosurgery/SBRT External Beam Radiation Therapy
Hide Arm/Group Description:

Radiosurgery/SBRT

Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments

External Beam Radiation Therapy

External Beam Radiation Therapy: 10 consecutive days of standard radiation

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Quality of Life
Hide Description Evaluate potential benefit of image-guided radiosurgery/SBRT on change in and overall quality of life as measured by FACT-G, BPI and EQ-5D
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
data not collected, therefore no analysis done
Arm/Group Title A/Radiosurgery-SBRT B/External Beam Radiation Therapy
Hide Arm/Group Description:
Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
External Beam Radiation Therapy: 10 consecutive days of standard radiation
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Long Term Effects of Image-guided Radiosurgery/SBRT
Hide Description Long term effects of image-guided radiosurgery/SBRT on the vertevral bone and spinal cord
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
data not collected, therefore no analysis done
Arm/Group Title A/Radiosurgery-SBRT B/External Beam Radiation Therapy
Hide Arm/Group Description:
Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
External Beam Radiation Therapy: 10 consecutive days of standard radiation
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Survival
Hide Description Progrsesion Free and Overall Survival
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
data not collected, therefore no analysis done
Arm/Group Title A/Radiosurgery-SBRT B/External Beam Radiation Therapy
Hide Arm/Group Description:
Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
External Beam Radiation Therapy: 10 consecutive days of standard radiation
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description Adverse events were monitored but none occurred.
 
Arm/Group Title A/Radiosurgery-SBRT B/External Beam Radiation Therapy
Hide Arm/Group Description Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments External Beam Radiation Therapy: 10 consecutive days of standard radiation
All-Cause Mortality
A/Radiosurgery-SBRT B/External Beam Radiation Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A/Radiosurgery-SBRT B/External Beam Radiation Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A/Radiosurgery-SBRT B/External Beam Radiation Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/2 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Anand Mahadevan, MD
Organization: Beth Israel Deaconess Medical Center
Phone: 617-667-2345
Responsible Party: Anand Mahadevan, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01525745     History of Changes
Other Study ID Numbers: 10-294
First Submitted: December 13, 2011
First Posted: February 3, 2012
Results First Submitted: September 3, 2015
Results First Posted: August 29, 2016
Last Update Posted: March 6, 2017