Head and Neck CancerNCT02705833
Head and Neck Cancer Treatment Patterns and Outcomes Research Study in France, Germany, and Canada
An observational study of Head and Neck Cancer, run by Bristol-Myers Squibb.
Trial summary
The primary objective of the study is to characterize the medical management of squamous cell carcinoma head and neck (SCCHN) patients diagnosed with recurrent/metastatic (R/M) disease (between 01July2013 and 30 June 2014) in the real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 591 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to 6 Dec 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: Patients diagnosed with R/M SCCHN between 01July2013 and 30June2014
Who may be able to join
- Adult patient (18 years old or older) with a confirmed diagnosis or R/M head and neck, may be living or deceased at time of enrollment in the study
- Diagnosis of R/M head and neck cancer between 01July2013 and 30June2014 (study index period)
Who cannot join
- If female patient, pregnant or lactating between 01July2013 and 30June2014
- Enrolled in cancer treatment-clinical trials since diagnosis of R/M head and neck cancer during the study index period
About this study
The primary objective of the study is to characterize the medical management of squamous cell carcinoma head and neck (SCCHN) patients diagnosed with recurrent/metastatic (R/M) disease (between 01July2013 and 30 June 2014) in the real-world setting.
- Conditions
- Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Population with R/M SCCHN | Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN) patients diagnosed between 01July2013 and 30June2014, alive or deceased, at the time of data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Therapy Response defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) based on physician's assessment for each therapy regimen
Measured: approximately 12 months
Overall Survival(OS) of patients with an Index diagnosis of R/M SCCHN
Measured: approximately 12 months
Progression-Free Survival(PFS) of patients with an Index diagnosis of R/M SCCHN
Measured: approximately 12 months
Recurrent-Free Survival(RFS) of patients with an Index diagnosis of R/M SCCHN
Measured: approximately 12 months
Overall Response Rate(ORR) of patients with an Index diagnosis of R/M SCCHN
Measured: approximately 12 months
Secondary outcomes (3)
Frequency of R/M SCCHN-related health care resource use
Measured: approximately 12 months
Treatment selection conditional on patient demographics, comorbidities, disease severity, and other characteristics as well as clinician demographics, therapy preferences, and other characteristics
Measured: approximately 12 months
Best Therapy Response conditional on patient demographics, comorbidities, disease severity, treatment received, and other characteristics
Measured: approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startDec 2015
- Primary completion6 Dec 2016
- Study completion6 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- 591 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705833
- Sponsor's protocol ID
- CA209-551
- Status last verified
- Apr 2017
- First submitted
- 25 Feb 2016
- Last updated
- 24 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head and Neck Cancer Treatment Patterns and Outcomes Research Study in France, Germany, and Canada
- ClinicalTrials.gov ID
- NCT02705833
- Acronym / sponsor ID
- CA209-551
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- 6 Dec 2016 (actual)
- Study completion
- 6 Dec 2016 (actual)
- First posted
- 11 Mar 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.
The primary objective of the study is to characterize the medical management of squamous cell carcinoma head and neck (SCCHN) patients diagnosed with recurrent/metastatic (R/M) disease (between 01July2013 and 30 June 2014) in the real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population with R/M SCCHN | – | –Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN) patients diagnosed between 01July2013 and 30June2014, alive or deceased, at the time of data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with R/M SCCHN between 01July2013 and 30June2014
Key inclusion criteria (2 listed)
- Adult patient (18 years old or older) with a confirmed diagnosis or R/M head and neck, may be living or deceased at time of enrollment in the study
- Diagnosis of R/M head and neck cancer between 01July2013 and 30June2014 (study index period)
Key exclusion criteria (2 listed)
- If female patient, pregnant or lactating between 01July2013 and 30June2014
- Enrolled in cancer treatment-clinical trials since diagnosis of R/M head and neck cancer during the study index period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Best Therapy Response defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) based on physician's assessment for each therapy regimen
Time frame: approximately 12 months
Overall Survival(OS) of patients with an Index diagnosis of R/M SCCHN
Time frame: approximately 12 months
Progression-Free Survival(PFS) of patients with an Index diagnosis of R/M SCCHN
Time frame: approximately 12 months
Recurrent-Free Survival(RFS) of patients with an Index diagnosis of R/M SCCHN
Time frame: approximately 12 months
Overall Response Rate(ORR) of patients with an Index diagnosis of R/M SCCHN
Time frame: approximately 12 months
3 secondary outcomes
Frequency of R/M SCCHN-related health care resource use
Time frame: approximately 12 months
Treatment selection conditional on patient demographics, comorbidities, disease severity, and other characteristics as well as clinician demographics, therapy preferences, and other characteristics
Time frame: approximately 12 months
Best Therapy Response conditional on patient demographics, comorbidities, disease severity, treatment received, and other characteristics
Time frame: approximately 12 months
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 24 Apr 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by Bristol-Myers Squibb.
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 2 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 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Best Therapy Response defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) based on physician's assessment for each therapy regimen (time frame: approximately 12 months). The study lists 5 primary outcomes in all. 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 24 Apr 2017.