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Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00551369
First received: October 30, 2007
Last updated: September 6, 2016
Last verified: September 2016
Results First Received: September 6, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Intervention: Radiation: SBRT

  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
No text entered.

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
SBRT Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy

Participant Flow:   Overall Study
    SBRT
STARTED   33 
COMPLETED   26 [1] 
NOT COMPLETED   7 
Protocol Violation                5 
Withdrawal by Subject                1 
Not treated per protocol and re                1 
[1] Subjects contributing data to the primary analysis are considered to have completed the study



  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 eligible patients who started study treatment

Reporting Groups
  Description
SBRT Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy

Baseline Measures
   SBRT 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Years]
Median (Full Range)
 73 
 (54 to 88) 
Gender 
[Units: Participants]
 
Female   15 
Male   11 


  Outcome Measures
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1.  Primary:   Primary Tumor Control at 2 Years   [ Time Frame: From start of treatment to 2 years. ]

2.  Secondary:   Rate of Treatment-related Grade 3 or 4 Toxicity   [ Time Frame: From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis. ]

3.  Secondary:   Other Grade 3-5 Adverse Events   [ Time Frame: From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis. ]

4.  Secondary:   Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years   [ Time Frame: From start of treatment to 2 years. ]

5.  Secondary:   Level of Comorbidity Burden on Morbidity and Efficacy   [ Time Frame: From start of treatment to end of follow-up. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Prediction of Primary Tumor Control at 2 Years and Treatment-related Adverse Events ≥ Grade 2   [ Time Frame: From start of treatment to 2 years. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org



Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00551369     History of Changes
Other Study ID Numbers: RTOG-0618
CDR0000571744
Study First Received: October 30, 2007
Results First Received: September 6, 2016
Last Updated: September 6, 2016
Health Authority: United States: Federal Government