Non-Small Cell Lung CancerNCT02658747
Neutropenic Sepsis in Patients With Non-Small Cell Lung Cancer Treated With Single-Agent Docetaxel and Associated Resource Use in the UK
An observational study of Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 7 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 120 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 25 May 2016to 25 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC)
Who may be able to join
- 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
Who cannot join
- Receiving docetaxel in an interventional clinical trial
- For whom no details of absolute neutrophil count are recorded
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
Velindre Cancer Centre
Cardiff, CF14 2TL
Chelsea & Westminster Hospital
London, SW10 9NH
Maidstone Hospital; Kent Oncology Centre
Maidstone, ME16 0FS
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, OX3 7LE
Royal Cornwall Hospital
Truro, TR1 3LQ
Pinderfields General Hospital; Dept of Haematology
Wakefield, WF1 4DG
About this study
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
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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- No intervention
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention administered in this study
| Study group | Role | What they receive |
|---|---|---|
| Cohort Docetaxel | Participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Up to 6 years
Percentage of Participants with Docetaxel-Related Hematological Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia
Measured: 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
Measured: Up to 6 years
Number of Episodes of NS with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L
Measured: Up to 6 years
Number of Episodes of NS Associated with Death Attributable to NS
Measured: Up to 6 years
Percentage of Deaths Associated with the Occurrence of an NS Event
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study start25 May 2016
- Primary completion25 Jul 2016
- Study completion25 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658747
- Sponsor's protocol ID
- ML30033
- Status last verified
- May 2017
- First submitted
- 15 Jan 2016
- Last updated
- 8 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02658747
- Acronym / sponsor ID
- ML30033
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 25 May 2016 (actual)
- Primary completion
- 25 Jul 2016 (actual)
- Study completion
- 25 Jul 2016 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort Docetaxel | – | Other: No interventionParticipants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Receiving docetaxel in an interventional clinical trial
- For whom no details of absolute neutrophil count are recorded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention administered in this study | Other | Cohort Docetaxel |
Primary outcome
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
Time frame: Up to 6 years
7 secondary outcomes
Frequency with which Participants Attend Hospital for Management of Specified Hematological Docetaxel-Related Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia
Time frame: 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
Time frame: Up to 6 years
Percentage of Participants with Docetaxel-Related Hematological Toxicities, Including Anemia, Thrombocytopenia, Neutropenia, Neutropenic Infection and Pancytopenia
Time frame: 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
Time frame: Up to 6 years
Number of Episodes of NS with an Absolute Neutrophil Count of Less Than 0.5 x 10^9/L
Time frame: Up to 6 years
Number of Episodes of NS Associated with Death Attributable to NS
Time frame: Up to 6 years
Percentage of Deaths Associated with the Occurrence of an NS Event
Time frame: Up to 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.