A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
May 20, 2010 updated by: AstraZeneca
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
The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China
- Research Site
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Guangdong
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Guangzhou, Guangdong, China
- Research Site
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Hubei
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Wuhan, Hubei, China
- Research Site
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Jiangsu
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Nanjing, Jiangsu, China
- Research Site
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Suzhou, Jiangsu, China
- Research Site
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Shandong
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Jinan, Shandong, China
- Research Site
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Shanghai
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Shanghai, Shanghai, China
- Research Site
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Sichuan
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Chengdu, Sichuan, China
- Research Site
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Zhejiang
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Hangzhou, Zhejiang, China
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment
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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.
Ki-67 protein expression in tissue will be analysed by IHC method.
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No Intervention: 2
Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP
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|
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No Intervention: 3
Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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Describe the quality of life of long-term survivors who are not terminated from the EAP
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Secondary Outcome Measures
Outcome Measure |
|---|
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To describe the current tumour control status via RECIST
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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.)
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To describe the treatment compliance of gefitinib in these patients
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To describe the current clinical status of long-term survivors in the EAP program by clinical
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Karen Atkin, AstraZeneca
- Study Chair: Louis Zhang, AstraZeneca
- Principal Investigator: Longyun Li, Peking Union Medical College Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
September 7, 2009
First Submitted That Met QC Criteria
October 22, 2009
First Posted (Estimate)
October 23, 2009
Study Record Updates
Last Update Posted (Estimate)
May 21, 2010
Last Update Submitted That Met QC Criteria
May 20, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1839IL/0052 SubStudy
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.