Stereotactic Boost for Locally Advanced Non-Small Cell Lung Cancer

This study has been terminated.
(Slow accrual due to restrictive eligibility criteria)
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Raymond H. Mak, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01222572
First received: October 8, 2010
Last updated: August 25, 2014
Last verified: August 2014
Results First Received: August 25, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Non-small Cell Lung Cancer
Lung Cancer
NSCLC
Intervention: Radiation: Stereotactic radiotherapy

  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
Experimental Arm Standard concurrent chemoradiation followed by two fraction SBRT boost

Participant Flow:   Overall Study
    Experimental Arm  
STARTED     1  
COMPLETED     1  
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
Experimental Arm Standard concurrent chemoradiation followed by two fraction SBRT boost

Baseline Measures
    Experimental Arm  
Number of Participants  
[units: participants]
  1  
Age  
[units: years]
Mean ( Full Range )
  68  
  ( 68 to 68 )  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     1  
Gender  
[units: participants]
 
Female     1  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures

1.  Primary:   Phase I: Maximally Tolerated Dose (MTD) of Stereotactic Boost Radiotherapy   [ Time Frame: 2 years ]

2.  Primary:   Phase II: Two-year Local Control Rate Following Stereotactic Boost Radiotherapy   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Risk of Grade 2-3 Radiation Pneumonitis   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Overall Survival Rate   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Disease-free Survival Rate   [ Time Frame: 2 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Regional Control Rate   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Change in Pulmonary Function   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting 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
- study was closed due to poor accrual after enrollment of 1 patients and results of trial are not interpretable.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Raymond Mak, MD
Organization: Dana-Farber Cancer Institute/Brigham and Women's Hospital
phone: 6177328651
e-mail: rmak@partners.org


No publications provided


Responsible Party: Raymond H. Mak, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01222572     History of Changes
Other Study ID Numbers: 10-240
Study First Received: October 8, 2010
Results First Received: August 25, 2014
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board