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

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 Overview

• Status: Completed
• Conditions: Head and Neck Cancer

• Study Type: Observational
• Enrollment (Actual): 591

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with R/M SCCHN between 01July2013 and 30June2014

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
Overall Response Rate(ORR) of patients with an Index diagnosis of R/M SCCHN	approximately 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of R/M SCCHN-related health care resource use	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	approximately 12 months
Best Therapy Response conditional on patient demographics, comorbidities, disease severity, treatment received, and other characteristics	approximately 12 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 6, 2016
• Study Completion (Actual): December 6, 2016

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: March 7, 2016
• First Posted (Estimate): March 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 24, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: CA209-551