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A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa

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: NCT01000740
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : May 21, 2010
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE September 7, 2009
First Posted Date  ICMJE October 23, 2009
Last Update Posted Date May 21, 2010
Study Start Date  ICMJE August 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
Describe the quality of life of long-term survivors who are not terminated from the EAP
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
  • To describe the current tumour control status via RECIST
  • To collect the risk factors related to prognosis in addition to the information already collected from EAP (age, gender, histology, smoking history, previous history of anti-cancer treatment, disease stage before starting gefitinib treatment, etc.)
  • To describe the treatment compliance of gefitinib in these patients
  • To describe the current clinical status of long-term survivors in the EAP program by clinical
  • To compare the key clinical features (age group, gender, histology, smoking history, disease stage, treatment-naive or pre-treated, response to prior chemotherapy,) in fast-progressors versus long-term survivals.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
Official Title  ICMJE An International Expanded Access Clinical Programme With ZD1839 (IRESSATM) for Patients With Advanced Non-small Cell Lung Cancer (NSCLC) China Amendment 1: A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
Brief Summary The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Genetic: EGFR Mutation Test
    Explore the EGFR mutation status from both tumour tissue sample and the free DNA in the peripheral blood using appropriate method(s) which may include ARMS assay, ME-PCR coupled sequencing and regular sequencing.
  • Genetic: Ki-67 protein expression
    Ki-67 protein expression in tissue will be analysed by IHC method.
Study Arms  ICMJE
  • Experimental: 1
    Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment
    Interventions:
    • Genetic: EGFR Mutation Test
    • Genetic: Ki-67 protein expression
  • No Intervention: 2
    Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP
  • No Intervention: 3
    Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being
Publications * Li L, Zhong W, Liao M, Chen L, Han B, Guan Z, Yu S, Liu X, Wu Y, Jiang G, Xu J, Chen J, Tao M, Luo R, Li W, Xu N, Zhao X, Wang M. [A study on the long-term non-small cell lung cancer survivors in the Expand Access Program of gefitinib in China]. Zhongguo Fei Ai Za Zhi. 2012 Jun;15(6):332-9. doi: 10.3779/j.issn.1009-3419.2012.06.03. Chinese.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2010)
59
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2009)
76
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures.
  • Participated in the Iressa EAP in China.
  • Diagnosed as NSCLC.
  • Patients who started EAP at least 3 years before this study initiated and have not yet terminated from the EAP (active long-term survivors).
  • Patients who consent to provide blood sample and available archival tumour tissue sample for EGFR gene testing (provision of tumour tissue sample is optional).

Exclusion Criteria:

  • Patients who disagree to participate this study.
  • Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01000740
Other Study ID Numbers  ICMJE 1839IL/0052 SubStudy
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MC MD, AstraZeneca China
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Karen Atkin AstraZeneca
Study Chair: Louis Zhang AstraZeneca
Principal Investigator: Longyun Li Peking Union Medical College Hospital
PRS Account AstraZeneca
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP