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Trial record 7 of 4050 for:    "Carcinoma, Non-Small-Cell Lung"

Study of Gefitinib Retreatment in Non-Small Cell Lung Cancer (NSCLC) (ReGaiN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00824746
Recruitment Status : Completed
First Posted : January 19, 2009
Results First Posted : February 26, 2013
Last Update Posted : February 26, 2013
Information provided by (Responsible Party):
Young-Chul Kim, Chonnam National University Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Intervention: Drug: Gefitinib retreatment

  Participant Flow

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
Gefitinib Retreatment Group Gefitinib retreatment group Patients who were previously treated with gefitinib followed by at least one line of cytotoxic chemotherapy can be enrolled to this retreatment group.

Participant Flow:   Overall Study
    Gefitinib Retreatment Group

  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
Single Arm Gefitinib retreatment

Baseline Measures
   Single Arm 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   9 
>=65 years   14 
[Units: Years]
Mean (Standard Deviation)
 64.9  (7.2) 
[Units: Participants]
Female   20 
Male   3 
Region of Enrollment 
[Units: Participants]
Korea, Republic of   23 

  Outcome Measures

1.  Primary:   Disease Control(DC) Rate of Gefitinib Retreatment Per RECIST Criteria (V1.1) and Assessed by CT   [ Time Frame: 8 weeks ]

2.  Secondary:   Progression - Free Survival of Patients Retreated With Gefitinib   [ Time Frame: two year ]

3.  Secondary:   Overall Survival   [ Time Frame: 2 years ]

  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
Our study has several limitations such as lack of generalizability outside a clinically and molecularly enriched population and the small number of repeat biopsies.

  More Information

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: Young-Chul Kim, MD, PhD
Organization: Chonnam National University Hwasun Hospital
phone: 82-61-379-7614
e-mail: kyc0923@jnu.ac.kr

Publications of Results:

Responsible Party: Young-Chul Kim, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT00824746     History of Changes
Other Study ID Numbers: D791JL00001
First Submitted: January 16, 2009
First Posted: January 19, 2009
Results First Submitted: February 9, 2012
Results First Posted: February 26, 2013
Last Update Posted: February 26, 2013