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

NCT03629691 | Completed

• 1 other identifier: OG317
• Study Type: observational
• Target: 187
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastric Cancer Metastatic to Lung; Lung Cancer

Keywords

Cavitation; PFS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• LRC (duration of locoregional control )

  From February 1, 2015 to May 19, 2018 , about 27 months

Study Arms (2)

gastric cancer lung metastatic

One of the study tumors.Between February 1, 2015 and May 19, 2018, 356adult patients with gastric adenocarcinoma, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University, of them, 110 patients with lung metastasis. 28 patients with lung cavitation

Other: lung cavitation

NSCLC

One of the study tumors.Between February 1, 2015 and May 19, 2018, 77 adult patients with primary lung cancer, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University. 30 of 77 were squamous cell carcinoma and 47 of 77 were adenocarcinoma. 28 patients with lung cavitation.

Other: lung cavitation

Interventions

lung cavitation OTHER

apatinib treated patients developed lung cavitation

NSCLC; gastric cancer lung metastatic

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• Cardiac disease and hemorrhagic disease were excluded.
• Patients with lung cavitation before apatinib treated.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: August 14, 2018
• Study Start: February 1, 2015
• Primary Completion: May 19, 2018
• Study Completion: May 19, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-07