Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)

This study has been terminated.
(Treatment became standard.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Vicki Keedy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00664105
First received: April 19, 2008
Last updated: August 30, 2012
Last verified: August 2012
Results First Received: September 30, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: Carboplatin
Drug: Docetaxel
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
Recruitment Period = 2/18/2004 through 1/23/2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 66 people consented to take part in this study and of those, 1 was determined to be ineligible and 2 withdrew from the study prior to beginning protocol therapy.

Reporting Groups
  Description
Chemo-radio Therapy Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.

Participant Flow:   Overall Study
    Chemo-radio Therapy  
STARTED     63  
COMPLETED     39  
NOT COMPLETED     24  
Death                 3  
Withdrawal by Subject                 5  
Adverse Event                 9  
Disease progression                 7  



  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
Chemo-radio Therapy Patients will receive carboplatin and docetaxel will be given weekly for seven weeks during concurrent radiotherapy. After a 3-week rest, patients will receive treatment every 3 weeks for two cycles of consolidation treatment.

Baseline Measures
    Chemo-radio Therapy  
Number of Participants  
[units: participants]
  63  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     36  
>=65 years     27  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 1  
Gender  
[units: participants]
 
Female     25  
Male     38  
Region of Enrollment  
[units: participants]
 
United States     63  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: 14.95 months (average duration, on study date to off-study date) ]

2.  Secondary:   Overall Response Rate   [ Time Frame: on-study date to date of best response ]

3.  Secondary:   Time to Disease Progression   [ Time Frame: on-study date to date of progression ]

4.  Secondary:   Number of Participants With Adverse Events by Grade   [ Time Frame: 30 days after last treatment. ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Outcome measure #4, "Number of participants with AEs by grade", will not match the total number of participants in this study. Some participants have multiple events in one or more grade designations or some participants have no events at all.  


Results Point of Contact:  
Name/Title: Vicki Keedy, M.D.
Organization: Vanderbilt-Ingram Cancer Center
phone: (615) 322-4967


No publications provided


Responsible Party: Vicki Keedy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00664105     History of Changes
Other Study ID Numbers: VICC THO 0319, VU-VICC-THO-0319, VU-VICC-030269
Study First Received: April 19, 2008
Results First Received: September 30, 2010
Last Updated: August 30, 2012
Health Authority: United States: Federal Government