Optimal EGFR TKIs Treatment Strategies for Lung Adenocarcinoma Harboring EGFR Exon 19 Deletion Variants

Tumor Progression Clinical Trial

Official title:

Determine the Optimal EGFR TKIs Treatment Strategies for Lung Adenocarcinoma Harboring EGFR Exon 19 Deletion Variants : the Clinical Analysis and Cell Lines Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370860
• Other study ID #: 202002122RINC
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine the optimal EGFR TKIs treatment strategies for lung adenocarcinoma harboring EGFR exon 19 deletion variants

Description:

RNA extraction: The investigators will extract total RNA from cell lysates by using Tri-reagent (Molecular Research Center, Inc., Cincinnati, Ohio) and an RNA Mini Kit (Qiagen, Hilden, Germany) according to the manufacturer's instruction. RNA obtained from the Mini Kit column will be eluted. The quantity and quality of the purified RNA will be evaluated using a NanoDrop ND-1000 spectrophotometer will be stored at -80 °C for further mutational analyses.

Data acquisition: The investigators will record and follow participants' clinical information, including ethnicity, age, gender, smoking status, histological types, lung cancer stage (the TNM status), metastatic sites, ECOG score, CT/CXR imaging, chemotherapy or radiation treatment at the time of diagnosis of lung cancer and through the entire clinical courses. Specific marker such as TTF1, is used to ensure the diagnosis of primary lung tumor. Clinicopathologic stage assigns according to the seventh tumor-node-metastasis classification. The investigators assess the treatment responses according to the Response Evaluation Criteria in Solid Tumors (RECIST) using the unidimension method, and record the best response achieved per treatment. Treatment response, progression-free survival, and overall survival are recorded prospectively for further analysis.

Statistical analysis: All categorical variables will be analyzed with Pearson's χ² test, except where a small size required the use of Fisher's exact test. The progression-free survival curve and overall survival will be plotted by the Kaplan-Meier method and compared by the log-rank test. Multivariate analysis for overall survival will be performed using the Cox's proportional hazards model. Two-sided p-values of less than 0.05 is considered significant. All analyses will be performed using SPSS software (version 16.0 for Windows; SPSS Inc.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients have signed the informed consent (201103013RC and 201111039RIC) before 2019/12/31 and authorized the Institutional Review Board of Nation Taiwan University Hospital to review the new study for approving the usage of residual specimens.

• The residual samples from various sources, including surgical tissues, computed tomography (CT)-guided needle aspiration and/or biopsy, echo-guided needle aspiration and /or biopsy, bronchoscopic biopsy or brushing, bronchoalveolar lavage (BAL), endobronchial ultrasound guided needle aspiration, and lymph node aspiration, and pleural effusion specimens. The samples will be collected at the time of diagnostic procedure performed. All patients should sign an informed consent for purpose of using samples for molecular genetic testing.

• 1000 residual specimens will be used for the study.

Exclusion Criteria:

• Patients didn't sign the informed consent (201103013RC, 201111039RIC)

• The residual specimens are not qualified.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• EGFR Exon 19 Mutation
• Tumor Progression

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor size measurement for evaluating tumor progression	Tumor size is recorded using CT scan before the first day of of treatment and routine CT scan image is captured at each cycle of treatment to evaluate the growth of tumor.; According to RECIST (The Response Evaluation Criteria in Solid Tumors), tumor progression will be assigned based on (1) a sum measurement of original target lesions that has increased more than 20%, (2) the reappearance of the original target lesions, (3) appearance of new lesions, and (4) a new lymph node metastatic lesion which is more than 10mm in diameter. Statistically, patients will be divided into several groups according to Exon 19 deletion variants, which is detected before the first day of treatment. The clinicopathologic characteristics (sex, age, smoking history) will be enrolled in multivariate analysis.	"up to 5 years," "from date of treatment (EGFR TKIs) until the date of first documented progression