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

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

Study Description
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Brief Summary:
The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Genetic: EGFR Mutation Test Genetic: Ki-67 protein expression Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment
 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.
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


Outcome Measures
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Primary Outcome Measures :
  1. Describe the quality of life of long-term survivors who are not terminated from the EAP

Secondary Outcome Measures :
  1. To describe the current tumour control status via RECIST
  2. 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.)
  3. To describe the treatment compliance of gefitinib in these patients
  4. To describe the current clinical status of long-term survivors in the EAP program by clinical
  5. 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.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000740


Locations
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China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
Research Site
Suzhou, Jiangsu, China
China, Shandong
Research Site
Jinan, Shandong, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Karen Atkin AstraZeneca
Study Chair: Louis Zhang AstraZeneca
Principal Investigator: Longyun Li Peking Union Medical College Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MC MD, AstraZeneca China
ClinicalTrials.gov Identifier: NCT01000740    
Other Study ID Numbers: 1839IL/0052 SubStudy
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: May 21, 2010
Last Verified: May 2010
Keywords provided by AstraZeneca:
EAP
Long term survival (3 years)
Gefitinib
efficacy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms