NCT02658747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

May 25, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2016

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

January 15, 2016

Last Update Submit

May 3, 2017

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

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

    Up to 6 years

Secondary Outcomes (7)

  • 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

  • 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 Participants with Docetaxel-Related Hematological 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

  • Number of Episodes of NS with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L

    Up to 6 years

  • +2 more secondary outcomes

Study Arms (1)

Cohort Docetaxel

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

Other: No intervention

Interventions

No interventionOTHER

No intervention administered in this study

Cohort Docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Location

Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

Location

Chelsea & Westminster Hospital

London, SW10 9NH, United Kingdom

Location

Maidstone Hospital; Kent Oncology Centre

Maidstone, ME16 0FS, United Kingdom

Location

Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

Royal Cornwall Hospital

Truro, TR1 3LQ, United Kingdom

Location

Pinderfields General Hospital; Dept of Haematology

Wakefield, WF1 4DG, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 20, 2016

Study Start

May 25, 2016

Primary Completion

July 25, 2016

Study Completion

July 25, 2016

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

GB(7)