Clinical trial NCT02658747: Neutropenic Sepsis in Patients With Non-Small Cell Lung Cancer Treated With Single-Agent Docetaxel and Associated Resource Use in the UK
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-01-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC)

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Up to 6 years
Secondary outcomes:
measure: Frequency with which Participants Attend Hospital for Management of Specified Hematological Docetaxel-Related Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia
timeFrame: Up to 6 years
measure: 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
timeFrame: Up to 6 years
measure: Percentage of Participants with Docetaxel-Related Hematological Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia
timeFrame: Up to 6 years
measure: Number of Episodes of Neutropenic Sepsis (NS) with an Absolute Neutrophil Count of Less Than 1.0 x 10^9/L
timeFrame: Up to 6 years
measure: Number of Episodes of NS with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L
timeFrame: Up to 6 years
measure: Number of Episodes of NS Associated with Death Attributable to NS
timeFrame: Up to 6 years
measure: Percentage of Deaths Associated with the Occurrence of an NS Event
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital; Kent Oncology Centre
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust - Churchill Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
city: Wakefield
country: United Kingdom
facility: Pinderfields General Hospital; Dept of Haematology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: