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Trial record 1 of 1 for:    CALGB 30506
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Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00863512
First Posted: March 18, 2009
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
Results First Submitted: December 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: cisplatin
Drug: docetaxel
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
Drug: vinorelbine tartrate
Procedure: standard follow-up care

  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
Arm I (Chemotherapy) Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II (Observation) Patients receive standard care (observation).

Participant Flow:   Overall Study
    Arm I (Chemotherapy)   Arm II (Observation)
STARTED   17   17 
COMPLETED   3   17 
NOT COMPLETED   14   0 
Adverse Event                2                0 
Withdrawal by Subject                11                0 
Physician Decision                1                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
Arm I (Chemotherapy) Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II (Observation) Patients receive standard care (observation).
Total Total of all reporting groups

Baseline Measures
   Arm I (Chemotherapy)   Arm II (Observation)   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   17   34 
Age 
[Units: Years]
Median (Full Range)
 67 
 (43 to 78) 
 63 
 (49 to 77) 
 67 
 (43 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  52.9%      10  58.8%      19  55.9% 
Male      8  47.1%      7  41.2%      15  44.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      1   5.9%      1   2.9% 
Black or African American      2  11.8%      1   5.9%      3   8.8% 
White      15  88.2%      15  88.2%      30  88.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   17   17   34 


  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: Up to 12 years ]


  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: David Harpole, M.D.
Organization: Duke University Medical Center
e-mail: david.harpole@duke.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00863512     History of Changes
Other Study ID Numbers: CALGB-30506
CDR0000636895 ( Registry Identifier: NCI Physician Data Query )
First Submitted: March 17, 2009
First Posted: March 18, 2009
Results First Submitted: December 13, 2016
Results First Posted: March 27, 2017
Last Update Posted: March 27, 2017