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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802409
Recruitment Status : Not yet recruiting
First Posted : January 14, 2019
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Anhui Medical University

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

Condition or disease
Lung Cancer

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Real Word Study of Albumin-binding Taxol for Lung Cancer Treatment
Estimated Study Start Date : January 20, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 year ]
    overall survival is defined as the length of time from random assignment to death or to last contact.

  2. disease control rate [ Time Frame: 1 year ]
    Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1

  3. 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


Other Outcome Measures:
  1. 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.

  2. adverse events [ Time Frame: 1 year ]
    adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Confirmed by Histopathology or Cytology of Lung cancer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802409


Locations
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China, Anhui
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
Sponsors and Collaborators
The First Affiliated Hospital of Anhui Medical University
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Responsible Party: The First Affiliated Hospital of Anhui Medical University
ClinicalTrials.gov Identifier: NCT03802409    
Other Study ID Numbers: AHAT-105
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Within six months after the trial complete.
Access Criteria: The data will be disclosed within six months after completion of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital of Anhui Medical University:
Albumin-binding taxol
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases