Study for Patients With Lung Metastatic Advanced Gastric Cancer and NSCLC Treated With Apatinib

Lung Cancer Clinical Trial

Official title:

A Retrospective Study for Patients With Lung Metastatic Advanced Gastric Cancer or NSCLC Treated With Apatinib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629691
• Other study ID #: OG317
• Status: Completed
• Start date: February 1, 2015
• Est. completion date: May 19, 2018

Study information

• Verified date: July 2018
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here.

Description:

Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University. Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database. All patients were with Karnofsky performance status ≥70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions. Cardiac disease and hemorrhagic disease were excluded. All patients had pre-therapy chest computed tomography (CT) prior to apatinib treatment, and follow-up chest CT at least every 4 weeks. The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here. Other patient demographic and clinical data, including age, gender; stage of disease, apatinib administered inclusion and withdrawal date, adverse events, oncologic clinical response, comorbid conditions, and smoking history, were retrieved from the CRIS database.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: May 19, 2018
• Est. primary completion date: May 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma

2. Multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University.

3. Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database.

4. All patients were with Karnofsky performance status over 70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions.

Exclusion Criteria:

1. Cardiac disease and hemorrhagic disease were excluded.

2. Patients with lung cavitation before apatinib treated.

Related Conditions & MeSH terms

• Gastric Cancer Metastatic to Lung
• Lung Cancer
• Lung Neoplasms
• Stomach Neoplasms

Intervention

Other:
• lung cavitation
apatinib treated patients developed lung cavitation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS (progression-free survival)	Evaluation of the oncologic clinical response was based on the alternate, modified method. We concluded that incorporating an assessment of cavitation when measuring target lesions might more accurately reflect changes in tumor volume. It was used for target lesions in which the longest diameter of any cavitation (zero if no cavity presented) was subtracted from the longest total diameter of the lesion, with each measurement taken in the same plane, to provide an alternate measure that was used to calculate the sum of measurements for all target lesions.	From February 1, 2015 to May 19, 2018 ,about 27 months
Secondary	LRC (duration of locoregional control )	For metastatic lung cancer, LRC is the local control of metastatic lung tumor here.	From February 1, 2015 to May 19, 2018 , about 27 months