Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00096265
First received: November 9, 2004
Last updated: May 5, 2014
Last verified: October 2011
Results First Received: March 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Tumors Metastatic to Brain
Interventions: Drug: erlotinib hydrochloride
Radiation: 3-dimensional conformal radiation therapy
Radiation: stereotactic radiosurgery
Drug: temozolomide

  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
WBRT + SRS Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
Temozolomide + WBRT + SRS Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Erlotinib + WBRT + SRS Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.

Participant Flow:   Overall Study
    WBRT + SRS     Temozolomide + WBRT + SRS     Erlotinib + WBRT + SRS  
STARTED     45     40     41  
COMPLETED     44 [1]   40     41  
NOT COMPLETED     1     0     0  
Ineligible                 1                 0                 0  
[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.
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Reporting Groups
  Description
WBRT + SRS Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
Temozolomide + WBRT + SRS Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Erlotinib + WBRT + SRS Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
Total Total of all reporting groups

Baseline Measures
    WBRT + SRS     Temozolomide + WBRT + SRS     Erlotinib + WBRT + SRS     Total  
Number of Participants  
[units: participants]
  45     40     41     126  
Age  
[units: years]
Median ( Full Range )
  63  
  ( 42 to 89 )  
  63  
  ( 39 to 83 )  
  61  
  ( 46 to 85 )  
  63  
  ( 39 to 89 )  
Gender  
[units: participants]
       
Female     22     18     18     58  
Male     23     22     23     68  



  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: From randomizaton to date of death for last follow-up. Analysis occurs after all patients have been potentiall followed for 9 months. ]

2.  Secondary:   Time to CNS Progression   [ Time Frame: From the date of randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Quality-adjusted Survival as Measured by EuroQol 5-dimension Instrument   [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after the primary outcome analysis. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Change in Functional Assessment of Cancer Therapy-Brain Subscale Questionnaire   [ Time Frame: From randomization to three months. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change in Performance Status   [ Time Frame: From randomization to six months. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Change in Steroid Dependence   [ Time Frame: From randomization to six months. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Cause of Death (Neurologic vs Other)   [ Time Frame: From randomization to date of death. ]
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 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: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group
e-mail: wseiferheld@acr.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096265     History of Changes
Other Study ID Numbers: NCI-2009-00720, NCI-2009-00720, CDR0000389490, RTOG 0320, RTOG 0320, RTOG-0320, U10CA021661
Study First Received: November 9, 2004
Results First Received: March 5, 2013
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration