A Non-interventional Retrospective Study on Overall Survival in Completely Resected Chinese NSCLC Patients With Adenocarcinoma Histology- ICAN Extension Study

Overall Survival Clinical Trial

Official title:

Guangdong Association of Clinical Trials

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03658928
• Other study ID #: CTONG1802
• Status: Not yet recruiting
• Start date: August 31, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: March 2018
• Source: Guangdong Association of Clinical Trials
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

ICAN was a non-interventional study to explore the EGFR gene mutation status, clinical outcome and recurrent risk factors in early stage Chinese NSCLC with adenocarcinoma histology after complete resection (NIS-OCN-DUM-2009/1). The study had enrolled 571 patients from Apr. 2010 to Dec. 2010 in 24 sites located in the mainland of China. The study had completed and major results showed that EGFR mutation rate was 55.1% and 3-year DFS rate was 61.7% in early stage Chinese NSCLC with adenocarcinoma histology after complete resection. Postoperative pathologic stage, gender, surgical and resection types had a statistically significant association with 3-year DFS.

This study is ICAN extension study with the purpose to collect the overall survival data from previous ICAN study. Approximately 571 patients who participated in ICAN study will be enrolled.

Description:

Primary objective

• To observe the overall survival of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study.

Secondary objectives

• To observe the updated DFS of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study;

• To observe the treatment pattern after tumor recurrence of early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting;

• To explore the risk factors of OS for early stage NSCLC with adenocarcinoma histology after complete resection that had enrolled in I CAN study in real-world setting, such as EGFR mutation status, gender, smoking history, treatment pattern after recurrence, etc.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 571
• Est. completion date: April 30, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients =18 years old.

2. Provision of informed consent prior to any study specific procedures

3. Histological diagnosed as adenocarcinoma type of non-small cell lung cancer

4. Have completed lung cancer operation

5. The tumour EGFR gene mutation status test was performed as regular medical practice

Exclusion Criteria:

1. No provision of informed consent or EC approve informed consent waiver prior to any study specific procedures;

2. Patients withdrew consent for ICAN study;

3. Patients in whose medical record was objected to use the existing data for scientific research

Related Conditions & MeSH terms

• Overall Survival

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	is defined as the time from the date of operation to date of death. For patients who are still alive, the last date when the patient is known to be alive will be used to determine the censoring date.	from the date of operation to date of death from any cause, whichever came first, assessed up to 8 years.
Secondary	Disease free survival	is defined as the time from operation until recurrence of tumor or death from any cause, whichever occurs first.	•from operation until recurrence of tumor or death from any cause, whichever came first, assessed up to 8 years.