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

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Other: No intervention

• Registration Number: NCT02658747
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-15
• Study First Posted: 2016-01-20
• Study Start: 2016-05-25
• Primary Completion: 2016-07-25
• Study Completion: 2016-07-25
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort Docetaxel	No intervention	Participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC)

Primary Outcome Measures

Name	Time	Method
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	Up to 6 years

Secondary Outcome Measures

Name	Time	Method
Frequency with which Participants Attend Hospital for Management of Specified Hematological Docetaxel-Related Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia	Up to 6 years
Number of Episodes of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 1.0 x 10^9/L	Up to 6 years
Percentage of Participants with Docetaxel-Related Hematological Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia	Up to 6 years
Number of Episodes of NS Associated with Death Attributable to NS	Up to 6 years
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	Up to 6 years
Percentage of Deaths Associated with the Occurrence of an NS Event	Up to 6 years
Number of Episodes of NS with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L	Up to 6 years

Trial Locations

Locations (7)

Velindre Cancer Centre; 🇬🇧 Cardiff, United Kingdom

Oxford University Hospitals NHS Trust - Churchill Hospital; 🇬🇧 Oxford, United Kingdom

Pinderfields General Hospital; Dept of Haematology; 🇬🇧 Wakefield, United Kingdom

Royal Cornwall Hospital; 🇬🇧 Truro, United Kingdom

Chelsea & Westminster Hospital; 🇬🇧 London, United Kingdom

Maidstone Hospital; Kent Oncology Centre; 🇬🇧 Maidstone, United Kingdom

Bristol Haematology and Oncology Centre; 🇬🇧 Bristol, United Kingdom