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Radiofrequency Ablation and External-Beam Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00499447
First received: July 10, 2007
Last updated: September 22, 2015
Last verified: September 2015
Results First Received: January 25, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Procedure: radiofrequency ablation
Radiation: radiation therapy

  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
Participants were recruited from the Radiation Oncology Clinic at the Comprehensive Cancer Center of Wake Forest University.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Radiofrequency Ablation Combined With External No text entered.

Participant Flow:   Overall Study
    Radiofrequency Ablation Combined With External
STARTED   13 
COMPLETED   13 
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.
No text entered.

Reporting Groups
  Description
Radiofrequency Ablation Combined With External No text entered.

Baseline Measures
   Radiofrequency Ablation Combined With External 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   4 
>=65 years   9 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.5  (9.7) 
Gender 
[Units: Participants]
 
Female   4 
Male   9 
Region of Enrollment 
[Units: Participants]
 
United States   13 


  Outcome Measures

1.  Primary:   Two Year Progression Free Survival Rate   [ Time Frame: 2 years ]

2.  Secondary:   Rate of Acute and Late Treatment-related Toxicity (Per CTCAE, v3.0) Related to Specific Symptoms   [ Time Frame: two years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
adverse events were tracked in two cycles, one during treatment and one longer term


  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. James Urbanic
Organization: Comprehensive Cancer Center of Wake Forest University
phone: 336-713-3600
e-mail: jurbanic@wakehealth.edu



Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00499447     History of Changes
Other Study ID Numbers: CDR0000555009
CCCWFU 62306 ( Other Identifier: CCCWFU )
IRB00001334 ( Other Identifier: WFUHS IRB )
Study First Received: July 10, 2007
Results First Received: January 25, 2013
Last Updated: September 22, 2015
Health Authority: United States: Institutional Review Board