Clinical trial NCT01000740: A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-small Cell Lung Cancer
Keywords: EAP
Long term survival (3 years)
Gefitinib
efficacy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-10-23
Enrollment: 59
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Describe the quality of life of long-term survivors who are not terminated from the EAP
Secondary outcomes:
measure: To describe the current tumour control status via RECIST
measure: 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.)
measure: To describe the treatment compliance of gefitinib in these patients
measure: To describe the current clinical status of long-term survivors in the EAP program by clinical
measure: 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.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Suzhou
country: China
facility: Research Site
state: Jiangsu
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
affiliation: AstraZeneca
name: Karen Atkin
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Louis Zhang
role: STUDY_CHAIR
affiliation: Peking Union Medical College Hospital
name: Longyun Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.