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NCT02705833 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02705833
Other study ID # CA209-551
Secondary ID
Status Completed
Phase N/A
First received February 25, 2016
Last updated April 21, 2017
Start date December 2015
Est. completion date December 6, 2016

Study information
Verified date April 2017
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 591
Est. completion date December 6, 2016
Est. primary completion date December 6, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Overall Survival(OS) of patients with an Index diagnosis of R/M SCCHN approximately 12 months
Primary Progression-Free Survival(PFS) of patients with an Index diagnosis of R/M SCCHN approximately 12 months
Primary Recurrent-Free Survival(RFS) of patients with an Index diagnosis of R/M SCCHN approximately 12 months
Primary Overall Response Rate(ORR) of patients with an Index diagnosis of R/M SCCHN approximately 12 months
Secondary Frequency of R/M SCCHN-related health care resource use approximately 12 months
Secondary 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
Secondary Best Therapy Response conditional on patient demographics, comorbidities, disease severity, treatment received, and other characteristics approximately 12 months
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