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Neoadjuvant Chemo for Non-metastatic Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01860040
Recruitment Status : Terminated (Poor accrual, no data to analyze)
First Posted : May 22, 2013
Results First Posted : October 25, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
Interventions: Drug: Cisplatin
Drug: Pemetrexed
Drug: Gemcitabine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
did not meet recruitment goal

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
Cisplatin and Pemetrexed

Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles

Cisplatin

Pemetrexed

Cisplatin and Gemcitabine

Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles

Cisplatin

Gemcitabine


Participant Flow:   Overall Study
    Cisplatin and Pemetrexed   Cisplatin and Gemcitabine
STARTED   1 [1]   0 [1] 
COMPLETED   0 [1]   0 [1] 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 
[1] did not meet recruitment goal



  Baseline Characteristics

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
Cisplatin and Pemetrexed

Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles

Cisplatin

Pemetrexed

Cisplatin and Gemcitabine

Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles

Cisplatin

Gemcitabine

Total Total of all reporting groups

Baseline Measures
   Cisplatin and Pemetrexed   Cisplatin and Gemcitabine   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   0   1 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%   0      0   0.0% 
Between 18 and 65 years      1 100.0%   0      1 100.0% 
>=65 years      0   0.0%   0      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1 100.0%   0      1 100.0% 
Male      0   0.0%   0      0   0.0% 


  Outcome Measures

1.  Primary:   Rate of Pathologic Complete Responses (pCR) at the Time of Definitive Surgical Resection of Non-small Cell Lung Cancer   [ Time Frame: One year ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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


Results Point of Contact:  
Name/Title: Director of Clinical Research
Organization: Western Regional Medical Center
phone: 6232073000
e-mail: westerntrials@ctca-hope.com



Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01860040     History of Changes
Other Study ID Numbers: 13-04
First Submitted: May 17, 2013
First Posted: May 22, 2013
Results First Submitted: April 26, 2016
Results First Posted: October 25, 2017
Last Update Posted: December 5, 2017