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A Comparison of FLT to FDG PET/CT in the Early Assessment of Chemotherapy Response in Stage IB-IIIA Resectable NSCLC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00963807
First received: August 18, 2009
Last updated: January 27, 2017
Last verified: January 2017
Results First Received: October 17, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Recurrent Non-Small Cell Lung Carcinoma
Stage IB Non-Small Cell Lung Carcinoma
Stage IIA Non-Small Cell Lung Carcinoma
Stage IIB Non-Small Cell Lung Carcinoma
Stage IIIA Non-Small Cell Lung Cancer
Stage IV Non-Small Cell Lung Cancer
Interventions: Drug: Cisplatin
Procedure: CT
Drug: Docetaxel
Drug: FDG
Drug: FLT
Procedure: PET/CT
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
Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)

Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.

Cisplatin: Given IV

Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT

Dexamethasone: Given PO

Docetaxel: Given IV

Fludeoxyglucose F-18: Undergo FDG PET/CT

Fluorothymidine F-18: Undergo FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies

Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT

Therapeutic Conventional Surgery: Undergo surgery


Participant Flow:   Overall Study
    Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)
STARTED   26 
Completed Baseline Imaging   11 
Completed Post-Cycle 1 Imaging   9 
Completed Post-Cycle 2 FLT Imaging   9 
Completed Post-Cycle 2 FDG Imaging   8 
COMPLETED   8 
NOT COMPLETED   18 
Physician Decision                2 
Reaction to study chemotherapy regimen                1 
Disease progression                15 



  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, Cisplatin, Dexamethasone, and Surgery)

Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.

Cisplatin: Given IV

Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT

Dexamethasone: Given PO

Docetaxel: Given IV

Fludeoxyglucose F-18: Undergo FDG PET/CT

Fluorothymidine F-18: Undergo FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies

Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT

Therapeutic Conventional Surgery: Undergo surgery


Baseline Measures
   Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery) 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Years]
Mean (Full Range)
 56.4 
 (33 to 77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  36.4% 
Male      7  63.6% 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in 18F-Fluorothymidine (FLT) Uptake   [ Time Frame: Baseline and 3 weeks ]

2.  Primary:   Change in FLT Uptake   [ Time Frame: Baseline and 6 weeks ]

3.  Primary:   Change in FLT Uptake in Responders and Non-responders   [ Time Frame: Baseline and 6 weeks ]

4.  Secondary:   Change in 18F-Fluorodeoxyglucose (FDG) Uptake   [ Time Frame: Baseline and 6 weeks ]

5.  Secondary:   Overall Response Rate Reported as a Proportion of the Total Number of Patients Who Received at Least One Cycle of Therapy Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Up to 6 weeks ]


  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: John P Crandall
Organization: Washington University in St. Louis
phone: (314) 747 - 5561
e-mail: jcrandall@wustl.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00963807     History of Changes
Other Study ID Numbers: NCI-2012-02899
NCI-2012-02899 ( Other Identifier: CTRP (Clinical Trial Reporting Program) )
NA_00017885 ( Other Identifier: Johns Hopkins Medicine IRBs )
J08134 ( Other Identifier: JHU/Sidney Kimmel Comprehensive Cancer Center )
NCI 8340 ( Other Identifier: CTEP )
N01CM00070 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
Study First Received: August 18, 2009
Results First Received: October 17, 2016
Last Updated: January 27, 2017