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

January 18, 2019 updated by: The First Affiliated Hospital of Anhui Medical University
The investigators conduct the real world study to explore the efficacy and safety of Albumin-binding taxol in lung cancer .

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • First Affiliated Hospital of Anhui Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Confirmed by Histopathology or Cytology of Lung cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress free survival
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 3 year
overall survival is defined as the length of time from random assignment to death or to last contact.
3 year
disease control rate
Time Frame: 1 year
Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1
1 year
Objective tumor response rate
Time Frame: 1 year
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score
Time Frame: 1 year
Quality of life score is a questionnaire developed to assess the quality of life of cancer patients.
1 year
adverse events
Time Frame: 1 year
adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Anhui Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 20, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 18, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHAT-105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

Within six months after the trial complete.

IPD Sharing Access Criteria

The data will be disclosed within six months after completion of the study.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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