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

NCT02705833 | Completed

• 1 other identifier: CA209-551
• Study Type: observational
• Target: 591
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• Investigator Inquiry Form

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 11, 2016
• Study Start: December 1, 2015
• Primary Completion: December 6, 2016
• Study Completion: December 6, 2016
• Last Updated: April 24, 2017

Record last verified: 2017-04