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

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT02705833
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-11
• Primary Completion: 2016-12-06
• Study Completion: 2016-12-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 591

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Overall Survival(OS) 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

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