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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658747
• Other study ID #: ML30033
• Status: Completed
• Phase: N/A
• First received: January 15, 2016
• Last updated: May 3, 2017
• Start date: May 25, 2016
• Est. completion date: July 25, 2016

Study information

• Verified date: May 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 25, 2016
• Est. primary completion date: July 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Other:
• No intervention
No intervention administered in this study

Locations

Country	Name	City	State
United Kingdom	Bristol Haematology and Oncology Centre	Bristol
United Kingdom	Velindre Cancer Centre	Cardiff
United Kingdom	Chelsea & Westminster Hospital	London
United Kingdom	Maidstone Hospital; Kent Oncology Centre	Maidstone
United Kingdom	Oxford University Hospitals NHS Trust - Churchill Hospital	Oxford
United Kingdom	Royal Cornwall Hospital	Truro
United Kingdom	Pinderfields General Hospital; Dept of Haematology	Wakefield

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Percentage of Participants with Docetaxel-Related Hematological Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia		Up to 6 years
Secondary	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
Secondary	Number of Episodes of NS with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L		Up to 6 years
Secondary	Number of Episodes of NS Associated with Death Attributable to NS		Up to 6 years
Secondary	Percentage of Deaths Associated with the Occurrence of an NS Event		Up to 6 years