Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00048997
First received: November 12, 2002
Last updated: September 30, 2014
Last verified: September 2014
Results First Received: September 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Radiation: Radiation therapy
Other: Observation

  Participant Flow
  Hide Participant Flow

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
Prophylactic Cranial Irradiation (PCI) PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
Observation Observation

Participant Flow:   Overall Study
    Prophylactic Cranial Irradiation (PCI)     Observation  
STARTED     176     180  
COMPLETED     163 [1]   177  
NOT COMPLETED     13     3  
Protocol Violation                 7                 2  
Withdrawal by Subject                 6                 1  
[1] Subjects contributing data to the primary analysis are considered to have completed the study.



  Baseline Characteristics
  Hide Baseline Characteristics

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 with consent.

Reporting Groups
  Description
Prophylactic Cranial Irradiation (PCI) PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
Observation Observation.
Total Total of all reporting groups

Baseline Measures
    Prophylactic Cranial Irradiation (PCI)     Observation     Total  
Number of Participants  
[units: participants]
  163     177     340  
Age  
[units: years]
Median ( Full Range )
  62  
  ( 38 to 81 )  
  60  
  ( 38 to 81 )  
  61  
  ( 38 to 81 )  
Gender  
[units: participants]
     
Female     60     67     127  
Male     103     110     213  



  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: After all patients have been potentially followed for a minimum of 12 months ]

2.  Secondary:   Neuropsychological Impact of Prophylactic Cranial Irradiation (PCI)   [ Time Frame: After all patients have been potentially followed for a minimum of 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Impact of PCI on Quality of Life   [ Time Frame: After all patients have been potentially followed for a minimum of 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Impact of PCI on Incidence of CNS Metastases   [ Time Frame: After all patients have been potentially followed for a minimum of 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
This study stopped accrual early due to unmet accrual goals.


  More Information
  Hide More Information

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
Organization: Radiation Therapy Oncology Group (RTOG)
e-mail: seiferheldw@nrgoncology.org


Publications of Results:
Other Publications:
Gondi V, Paulus R, Bruner D, et al.: Prognostic significance of QOL deterioration during early lung cancer survivorship: secondary analysis of RTOG 0212 and 0214. [Abstract] J Clin Oncol 29 (Suppl 15): A-6061, 2011.


Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00048997     History of Changes
Other Study ID Numbers: RTOG-0214, CDR0000257200, ECOG-RTOG-0214
Study First Received: November 12, 2002
Results First Received: September 30, 2014
Last Updated: September 30, 2014
Health Authority: United States: Federal Government