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NCT Number: NCT02658747

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bristol Haematology and Oncology Centre, Bristol, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention administered in this study

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 20, 2016
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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