The Real Word Study of Albumin-binding Taxol for Lung Cancer Treatment

Lung Cancer Clinical Trial

Official title:

The Real Word Study of Albumin-binding Taxol for Lung Cancer Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03802409
• Other study ID #: AHAT-105
• Status: Not yet recruiting
• Start date: January 20, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2019
• Source: The First Affiliated Hospital of Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators conduct the real world study to explore the efficacy and safety of Albumin-binding taxol in lung cancer .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 30, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female patients .

2. Confirmed by Histopathology or Cytology of Lung Cancer

3. Patients should be voluntary to the trial and provide with signed informed consent

4. The researchers believe patients can benefit from the study.

Exclusion Criteria:

1. Patients with a known history of allergic reactions and/or hypersensitivity attributed to Albumin-binding taxol or its accessories

2. Pregnant or lactating women

3. Patients with Albumin-binding taxol contraindications

4. Patients of doctors considered unsuitable for the trial

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
China	First Affiliated Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life score	Quality of life score is a questionnaire developed to assess the quality of life of cancer patients.	1 year
Other	adverse events	adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.	1 year
Primary	Progress free survival	Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.	1 year
Secondary	Overall Survival	overall survival is defined as the length of time from random assignment to death or to last contact.	3 year
Secondary	disease control rate	Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1	1 year
Secondary	Objective tumor response rate	Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments	1 year