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

NCT ID: NCT02658747

Last Updated: 2017-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-25

Study Completion Date

2016-07-25

Brief Summary

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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

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort Docetaxel

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

No intervention

Intervention Type OTHER

No intervention administered in this study

Interventions

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No intervention

No intervention administered in this study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Bristol Haematology and Oncology Centre

Bristol, , United Kingdom

Site Status

Velindre Cancer Centre

Cardiff, , United Kingdom

Site Status

Chelsea & Westminster Hospital

London, , United Kingdom

Site Status

Maidstone Hospital; Kent Oncology Centre

Maidstone, , United Kingdom

Site Status

Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford, , United Kingdom

Site Status

Royal Cornwall Hospital

Truro, , United Kingdom

Site Status

Pinderfields General Hospital; Dept of Haematology

Wakefield, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ML30033

Identifier Type: -

Identifier Source: org_study_id

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