Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

This study has been terminated.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00938457
First received: July 9, 2009
Last updated: June 4, 2012
Last verified: June 2012
Results First Received: June 4, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Unspecified Adult Solid Tumor
Interventions: Radiation: stereotactic radiation therapy
Procedure: implanted fiducial-based imaging
Procedure: cone-beam computed tomography

  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
Three patients were recruited at Mayo Clinic between January 2010 and May 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a phase I/II trial. A total of 3 participants were accrued, all to the phase I portion. This trial was terminated due to poor accrual. No patients were accrued to the phase II portion. No results from the phase II portion are available.

Reporting Groups
  Description
Arm I Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.

Participant Flow:   Overall Study
    Arm I  
STARTED     3  
COMPLETED     3  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
Arm I Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.

Baseline Measures
    Arm I  
Number of Participants  
[units: participants]
  3  
Age  
[units: years]
Median ( Full Range )
  60  
  ( 43 to 67 )  
Gender  
[units: participants]
 
Female     1  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures
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1.  Primary:   Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.   [ Time Frame: 2 months ]

2.  Primary:   Determine the Minimum Effective Dose (MED) Necessary for Durable Local Control, Defined as the Dose Level at Which Local Control (LC) is >= 80% at 1 Year. (Phase II)   [ Time Frame: At 1 year ]

3.  Secondary:   Toxicity and Adverse Events Profile (Phase I)   [ Time Frame: Up to 2 years ]

4.  Secondary:   Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase I)   [ Time Frame: Up to 2 years ]

5.  Secondary:   Radiographic Response Rate (Phase II)   [ Time Frame: Up to 2 years ]

6.  Secondary:   Local Control (LC) Cumulative Incidence Rates (Phase II)   [ Time Frame: 3 and 6 months and 1, 2, and 5 years ]

7.  Secondary:   Median Time to Progression of Treated Tumors (Phase II)   [ Time Frame: Up to 5 years ]

8.  Secondary:   Refinement of Toxicity and Adverse Events Profile (Phase II)   [ Time Frame: Up to 2 years ]

9.  Secondary:   Refinement of Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase II)   [ Time Frame: Up to 2 years ]

10.  Secondary:   Evaluation of Cause of Death (Phase II)   [ Time Frame: Up to 5 years ]


  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: Dr. Robert C. Miller
Organization: Mayo Clinic
phone: 507-284-2669
e-mail: miller.robert@mayo.edu


No publications provided


Responsible Party: Robert C. Miller, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00938457     History of Changes
Other Study ID Numbers: MC0941, MC0941, 09-000020, NCI-2009-01150
Study First Received: July 9, 2009
Results First Received: June 4, 2012
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration