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Radiofrequency Ablation in Treating Patients With Stage I Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00109876
First received: May 3, 2005
Last updated: November 29, 2016
Last verified: November 2016
Results First Received: November 29, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Intervention: Procedure: Computed Tomography-Guided Optical Sensor-Guided Radiofrequency Ablation

  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
Fifty-four (54) participants were enrolled from 16 institutions from December 2006 to November 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two participants had pre-RFA positron emission tomography (PET) not within 60 days before study preregistration and one participant did not had non-small cell lung cancer, which were deemed ineligible for the studies, and were excluded from all analyses.

Reporting Groups
  Description
RFA Therapy Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.

Participant Flow:   Overall Study
    RFA Therapy
STARTED   51 
COMPLETED   51 
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.
All enrolled participants who met the eligibility criteria.

Reporting Groups
  Description
RFA Therapy Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.

Baseline Measures
   RFA Therapy 
Overall Participants Analyzed 
[Units: Participants]
 51 
Age 
[Units: Years]
Median (Full Range)
 76 
 (60 to 89) 
Gender 
[Units: Participants]
Count of Participants
 
Female      28  54.9% 
Male      23  45.1% 
Region of Enrollment 
[Units: Participants]
 
United States   51 
Eastern Cooperative Oncology Group (ECOG)Performance Status 
[Units: Participants]
Count of Participants
 
0 = Asymptomatic and fully active      9  17.6% 
1= Symptomatic and fully ambulatory      29  56.9% 
2= Symptomatic and ambulatory      13  25.5% 
Baseline Forced Expiratory Volume in 1 second (FEV1) 
[Units: Percentage of predicted]
Median (Full Range)
 48 
 (13 to 102) 
Baseline diffusing capacity of the lung for carbon monoxide (DLCO) 
[Units: Percentage of predicted]
Median (Full Range)
 42 
 (7 to 99) 
Baseline forced vital capacity 
[Units: mL]
Median (Full Range)
 2070 
 (1090 to 3720) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival at 2 Years   [ Time Frame: 2 years from registration ]

2.  Secondary:   Overall Time to Local Failure   [ Time Frame: Up to 2 years ]

3.  Secondary:   Overall Time to Recurrence   [ Time Frame: Up to 2 years ]

4.  Secondary:   Proportion of Technical Success   [ Time Frame: Up to 2 years ]

5.  Secondary:   Incidence of Adverse Events   [ Time Frame: Up to 2 years ]

6.  Secondary:   Change in Pulmonary Function From Baseline at Month 3   [ Time Frame: Baseline and Month 3 ]

7.  Secondary:   Change in Pulmonary Function From Baseline at Month 24   [ Time Frame: Baseline and Month 24 ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Damian E. Dupuy, MD
Organization: Rhode Island Hospital/Alpert Medical School
phone: 401 - 444 - 5184
e-mail: ddupuy@lifespan.org



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00109876     History of Changes
Other Study ID Numbers: ACOSOG-Z4033
CDR0000426417 ( Registry Identifier: NCI Physician Data Query )
Study First Received: May 3, 2005
Results First Received: November 29, 2016
Last Updated: November 29, 2016