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Neutropenic Sepsis in Patients With Non-Small Cell Lung Cancer Treated With Single-Agent Docetaxel and Associated Resource Use in the UK

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658747
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a multi-center retrospective observational research study collecting data for participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC) up to 6 years before start of data collection and who have completed/stopped docetaxel treatment at least 30 days prior to data collection. The primary goal of this study is to describe the percentage of participants with at least one neutropenic sepsis (NS) episode following initiation of treatment with single-agent docetaxel. Data will be collected until end of docetaxel treatment plus an additional 30 days to allow for presentation with toxicity.

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer Other: No intervention

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Chart Review to Describe the Rate of Neutropenic Sepsis in Patients With Non-Small Cell Lung Cancer Treated With Single-Agent Docetaxel and Associated Resource Use in the UK
Actual Study Start Date : May 25, 2016
Actual Primary Completion Date : July 25, 2016
Actual Study Completion Date : July 25, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
Drug Information available for: Docetaxel

Group/Cohort Intervention/treatment
Cohort Docetaxel
Participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC)
Other: No intervention
No intervention administered in this study




Primary Outcome Measures :
  1. Percentage of Participants Receiving Single-Agent Docetaxel Chemotherapy for Treatment of Relapsed Non-Small Cell Lung Cancer (NSCLC) with an Episode of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 1.0 x 10^9/L [ Time Frame: Up to 6 years ]

Secondary Outcome Measures :
  1. Frequency with which Participants Attend Hospital for Management of Specified Hematological Docetaxel-Related Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia [ Time Frame: Up to 6 years ]
  2. Percentage of Participants Receiving Single-Agent Docetaxel Chemotherapy for Treatment of Relapsed Non-Small Cell Lung Cancer (NSCLC) with an Episode of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L [ Time Frame: Up to 6 years ]
  3. Percentage of Participants with Docetaxel-Related Hematological Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia [ Time Frame: Up to 6 years ]
  4. Number of Episodes of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 1.0 x 10^9/L [ Time Frame: Up to 6 years ]
  5. Number of Episodes of NS with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L [ Time Frame: Up to 6 years ]
  6. Number of Episodes of NS Associated with Death Attributable to NS [ Time Frame: Up to 6 years ]
  7. Percentage of Deaths Associated with the Occurrence of an NS Event [ Time Frame: Up to 6 years ]


Information from the National Library of Medicine

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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
Participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC)
Criteria

Inclusion Criteria:

  • Diagnosed with locally advanced or metastatic (stage Ill or IV) non-small cell lung cancer (NSCLC)
  • Relapsed disease following, or unable to tolerate, at least one line of prior chemotherapy
  • Initiated on single-agent docetaxel up to a maximum of 6 years prior to date of collection
  • Aged 18 years at date of first docetaxel dose
  • Completed or stopped treatment with docetaxel at least 30 days prior to date of data collection

Exclusion Criteria:

  • Receiving docetaxel in an interventional clinical trial
  • For whom no details of absolute neutrophil count are recorded

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): NCT02658747


Locations
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United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Chelsea & Westminster Hospital
London, United Kingdom, SW10 9NH
Maidstone Hospital; Kent Oncology Centre
Maidstone, United Kingdom, ME16 0FS
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Royal Cornwall Hospital
Truro, United Kingdom, TR1 3LQ
Pinderfields General Hospital; Dept of Haematology
Wakefield, United Kingdom, WF1 4DG
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02658747    
Other Study ID Numbers: ML30033
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms