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OpenTrials
Completed

NCT Number: NCT02705833

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: approximately 12 months

  2. Overall Survival(OS) of patients with an Index diagnosis of R/M SCCHN

    Time frame: approximately 12 months

  3. Progression-Free Survival(PFS) of patients with an Index diagnosis of R/M SCCHN

    Time frame: approximately 12 months

  4. Recurrent-Free Survival(RFS) of patients with an Index diagnosis of R/M SCCHN

    Time frame: approximately 12 months

  5. Overall Response Rate(ORR) of patients with an Index diagnosis of R/M SCCHN

    Time frame: approximately 12 months

Secondary outcomes

  1. Frequency of R/M SCCHN-related health care resource use

    Time frame: approximately 12 months

  2. Treatment selection conditional on patient demographics, comorbidities, disease severity, and other characteristics as well as clinician demographics, therapy preferences, and other characteristics

    Time frame: approximately 12 months

  3. Best Therapy Response conditional on patient demographics, comorbidities, disease severity, treatment received, and other characteristics

    Time frame: approximately 12 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2016
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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