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Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury

This study has been completed.
Sponsor:
Collaborator:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00580970
First received: December 20, 2007
Last updated: September 28, 2016
Last verified: September 2016
Results First Received: June 3, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Prostate Cancer
Intervention: Drug: lovastatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period was between between 2007 to 2013 at Virginia Commonwealth University, Stony Point, Hanover Medical Center, Southside Regional Medical Center, and Hunter Holmes McGuire Veterans Affairs Medical Center (VAMC).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrollment period was between April 12, 2007 and May 30, 2013. During that time 73 consecutive subjects enrolled in the study, 72 started treatment. A total of 20 subjects were ineligible for analysis because they did not reach 6 months of Lovastatin treatment, resulting in a total of 53 evaluable subjects.

Reporting Groups
  Description
Supportive Care (Lovastatin)

Subjects took Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued for 12 months.

73 subjects enrolled in the study, 72 started treatment, 20 subjects were ineligible for analysis, and a total of 53 evaluable subjects.


Participant Flow for 2 periods

Period 1:   Pre-treatment
    Supportive Care (Lovastatin)
STARTED   73 
COMPLETED   72 
NOT COMPLETED   1 
Non-compliance                1 

Period 2:   Treatment (Lovastatin)
    Supportive Care (Lovastatin)
STARTED   72 
6 Months of Treatment   53 [1] 
COMPLETED   53 
NOT COMPLETED   19 
Non-compliance                6 
Intolerance of Lovastatin                7 
Physician Decision                4 
Development of metastatic second primary                1 
Death                1 
[1] Subjects evaluable for analysis



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Between April 12, 2007 and May 30, 2013, 73 consecutive patients enrolled in the study. A total of 20 patients did not complete at least 6 months of Lovastatin treatment and were deemed ineligible for the purpose of assessing late rectal toxicity and additional patients were enrolled in order to achieve the accrual goal of 53 evaluable patients.

Reporting Groups
  Description
Supportive Care (Lovastatin) (Evaluable) The 53 subjects started Lovastatin treatment on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued up to 12 months. The subjects were considered evaluable for analysis because they completed 6 months of Lovastatin.
Supportive Care (Lovastatin) (Ineligible) The 20 subjects started Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy). The subjects were ineligible because they did not complete 6 months of Lovastatin.
Total Total of all reporting groups

Baseline Measures
   Supportive Care (Lovastatin) (Evaluable)   Supportive Care (Lovastatin) (Ineligible)   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   20   73 
Age 
[Units: Years]
Median (Full Range)
 63 
 (47 to 80) 
 58.5 
 (50 to 69) 
 62 
 (47 to 80) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   53   20   73 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   22   10   32 
White   31   10   41 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   53   20   73 


  Outcome Measures

1.  Primary:   Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mitchell S. Anscher, M.D. Professor and chairman
Organization: Virginia Commonwealth University/Massey Cancer Center
phone: 804-828-7238
e-mail: mitchell.anscher@vcuhealth.org



Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00580970     History of Changes
Other Study ID Numbers: MCC-10802
NCI-2011-01676 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: December 20, 2007
Results First Received: June 3, 2016
Last Updated: September 28, 2016
Health Authority: United States: Institutional Review Board