Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

This study has been terminated.
(low accrual)
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Heather Wakelee, Stanford University
ClinicalTrials.gov Identifier:
NCT00238615
First received: October 11, 2005
Last updated: May 29, 2013
Last verified: May 2013
Results First Received: September 24, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lung Cancer
Carcinoma, Non-Small-Cell Lung
Interventions: Drug: Docetaxel
Drug: Carboplatin
Procedure: Radiation therapy
Procedure: Surgical resection

  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
Docetaxel / Carboplatin / XRT + Surgical Resection Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival outcomes.

Participant Flow:   Overall Study
    Docetaxel / Carboplatin / XRT + Surgical Resection  
STARTED     13  
COMPLETED     13  
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
Group 1 No text entered.

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     6  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 24  
Gender  
[units: participants]
 
Female     7  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     13  



  Outcome Measures
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1.  Primary:   2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.   [ Time Frame: Two years ]

2.  Secondary:   Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival   [ Time Frame: baseline, 5 weeks after combined chemo-radiation ]

3.  Other Pre-specified:   Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen   [ Time Frame: Specimen collected at time of surgery ]


  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
Accrual was very slow. The study was halted with accrual of only 13 patients. These results were published.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Heather Wakelee
Organization: Stanford University
phone: 650-736-7221
e-mail: hwakelee@stanford.edu


Publications of Results:

Responsible Party: Heather Wakelee, Stanford University
ClinicalTrials.gov Identifier: NCT00238615     History of Changes
Other Study ID Numbers: LUN0002, 78999, GIA #12169, 11804
Study First Received: October 11, 2005
Results First Received: September 24, 2012
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board