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Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Michael Mann, Maestro Clinical, Inc.
ClinicalTrials.gov Identifier:
NCT00883675
First received: April 17, 2009
Last updated: October 29, 2013
Last verified: October 2013
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer
Intervention: Drug: Docetaxel-Carboplatin

  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
Enrollment of patients took place at a single center in the United States (Dartmouth-Hitchcock Norris Cotton Cancer Center) and at ten sites in China that were early members of the China Clinical Trials Consortium.

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
Treatment Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses

Participant Flow:   Overall Study
    Treatment  
STARTED     133  
COMPLETED     133  
NOT COMPLETED     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
Treatment Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses

Baseline Measures
    Treatment  
Number of Participants  
[units: participants]
  133  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     87  
>=65 years     46  
Age  
[units: years]
Mean ± Standard Deviation
  59.8  ± 9.3  
Gender  
[units: participants]
 
Female     44  
Male     89  
Region of Enrollment  
[units: participants]
 
United States     2  
China     131  



  Outcome Measures

1.  Primary:   Febrile Neutropenia   [ Time Frame: 2 months ]


  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
No text entered.


  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 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: Michael Mann, MD
Organization: Maestro
phone: 650-380-9579
e-mail: michael.mann@ucsfmedctr.org


No publications provided


Responsible Party: Michael Mann, Maestro Clinical, Inc.
ClinicalTrials.gov Identifier: NCT00883675     History of Changes
Other Study ID Numbers: MC#08-002, IIT 12230
Study First Received: April 17, 2009
Results First Received: October 29, 2013
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board
China: Ethics Committee