Trial record 1 of 1 for:    rtog and 0839
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Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00979212
First received: September 16, 2009
Last updated: June 30, 2016
Last verified: June 2016
Results First Received: June 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: panitumumab
Drug: carboplatin
Drug: paclitaxel
Procedure: surgery

  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
Induction CT+RT Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Induction CT+RT+Panitumumab Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)

Participant Flow:   Overall Study
    Induction CT+RT     Induction CT+RT+Panitumumab  
STARTED     24     47  
COMPLETED     22 [1]   39 [1]
NOT COMPLETED     2     8  
Protocol Violation                 1                 8  
No protocol therapy received                 1                 0  
[1] Subjects with data available for 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 receiving protocol treatment

Reporting Groups
  Description
Induction CT+RT Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Induction CT+RT+Panitumumab Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
Total Total of all reporting groups

Baseline Measures
    Induction CT+RT     Induction CT+RT+Panitumumab     Total  
Number of Participants  
[units: participants]
  22     39     61  
Age  
[units: years]
Median (Full Range)
  61  
  (51 to 77)  
  61  
  (32 to 78)  
  61  
  (32 to 78)  
Gender  
[units: participants]
     
Female     13     18     31  
Male     9     21     30  



  Outcome Measures
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1.  Primary:   Mediastinal Nodal Clearance After Completion of Induction Chemoradiotherapy With or Without Panitumumab.   [ Time Frame: From date of randomization to time of protocol surgery, approximately 12 weeks. ]

2.  Secondary:   Overall Survival   [ Time Frame: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study ]

3.  Secondary:   Patterns of First Failure   [ Time Frame: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study. ]

4.  Secondary:   Surgical Morbidities in Patients With Resectable Disease at Reassessment   [ Time Frame: From date of surgery to 30 days following surgery. ]

5.  Secondary:   Acute and Late Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0   [ Time Frame: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Ability of FDG-PET/CT Scan Data to Predict Outcome   [ Time Frame: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Response Rate   [ Time Frame: Patients are followed until death. Analysis occurs at time of primary analysis, approximately five years from start of study. ]
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
Following a recommendation on July 13, 2015 by the NRG Data Monitoring Committee the study was halted early after accruing only 71 of 97 patients due to unexpectedly high rates of grade 5 toxicity on the panitumumab arm.


  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: NCT00979212     History of Changes
Other Study ID Numbers: RTOG-0839
CDR0000654690
NCI-2011-01970 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
Study First Received: September 16, 2009
Results First Received: June 30, 2016
Last Updated: June 30, 2016
Health Authority: United States: Food and Drug Administration