Head and Neck Cancer Treatment Patterns and Outcomes Research Study in France, Germany, and Canada

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02705833

Enrollment

591

Registered

2016-03-11

Start date

2015-12-31

Completion date

2016-12-06

Last updated

2017-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Overall Response Rate(ORR) of patients with an Index diagnosis of R/M SCCHN	approximately 12 months
Overall Survival(OS) of patients with an Index diagnosis of R/M SCCHN	approximately 12 months
Progression-Free Survival(PFS) of patients with an Index diagnosis of R/M SCCHN	approximately 12 months
Recurrent-Free Survival(RFS) of patients with an Index diagnosis of R/M SCCHN	approximately 12 months
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	approximately 12 months

Secondary

Measure	Time frame
Treatment selection conditional on patient demographics, comorbidities, disease severity, and other characteristics as well as clinician demographics, therapy preferences, and other characteristics	approximately 12 months
Best Therapy Response conditional on patient demographics, comorbidities, disease severity, treatment received, and other characteristics	approximately 12 months
Frequency of R/M SCCHN-related health care resource use	approximately 12 months

Outcome results