Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer

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:
NCT01055197
First received: January 22, 2010
Last updated: August 26, 2016
Last verified: August 2016
Results First Received: August 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Radiation: Prophylactic Cranial Irradiation
Radiation: Radiation Therapy

  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
Prophylactic Cranial Irradiation Prophylactic Cranial Irradiation (PCI)
Prophylactic Cranial Irradiation + Consolidation Radiotherapy Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease

Participant Flow:   Overall Study
    Prophylactic Cranial Irradiation   Prophylactic Cranial Irradiation + Consolidation Radiotherapy
STARTED   51   46 
COMPLETED   42 [1]   44 [1] 
NOT COMPLETED   9   2 
Protocol Violation                7                2 
Withdrawal by Subject                2                0 
[1] Subjects with data available for 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 randomized and eligible patients

Reporting Groups
  Description
Prophylactic Cranial Irradiation Prophylactic Cranial Irradiation (PCI)
Prophylactic Cranial Irradiation + Consolidation Radiotherapy Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
Total Total of all reporting groups

Baseline Measures
   Prophylactic Cranial Irradiation   Prophylactic Cranial Irradiation + Consolidation Radiotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   44   86 
Age 
[Units: Years]
Median (Full Range)
 61 
 (47 to 81) 
 66 
 (35 to 86) 
 63 
 (35 to 86) 
Gender 
[Units: Participants]
     
Female   24   23   47 
Male   18   21   39 


  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months. ]

2.  Secondary:   Comparison of Treatment-related Adverse Events   [ Time Frame: From start of treatment to end of follow-up. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Patterns of Failure   [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Comparison of Time to First Failure   [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Evaluation of the Percentage of the Planned Radiotherapy Dose to Each Site   [ Time Frame: From start to end of radiation therapy. ]
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
At the first interim analysis of overall survival the data monitoring committee determined that due to the lack of evidence of potential efficacy and a higher than acceptable toxicity profile for the PCI+RT arm, study accrual would close early.


  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: NCT01055197     History of Changes
Other Study ID Numbers: RTOG 0937
CDR0000663959
NCI-2011-02008 ( Registry Identifier: Clinical Trial Reporting Program (CTRP) )
Study First Received: January 22, 2010
Results First Received: August 26, 2016
Last Updated: August 26, 2016
Health Authority: United States: Federal Government