Real-World Evidence and Treatment Patterns: Head and Neck Cancer

Head & Neck Cancer Clinical Trial

Official title:

Real-World Evidence and Treatment Patterns: Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157674
• Other study ID #: CA209-868
• Status: Completed
• Start date: November 24, 2016
• Est. completion date: April 20, 2020

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will be focused on HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43994
• Est. completion date: April 20, 2020
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HNC or undefined histology (not otherwise specified [NOS]) HNC diagnosis from 01-Jan-2013 to 30-Sep-2016 using Japanese disease code

• Age 18 years or older at initial diagnosis of HNC regardless of staging

Exclusion Criteria:

• Diagnosis of another malignancy on or before the initial diagnosis of HNC with the exception of non-melanoma skin cancer and metastatic cancer

• Diagnosis of HNC before 01-Jan 2013 or after 30-Sep-2016

Related Conditions & MeSH terms

• Head & Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
Japan	Local Institution	Tokyo	Shibuya-ku

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients receiving radiotherapy as anti-cancer treatment		Approximately 45 months
Primary	Proportion of patients receiving surgery as anti-cancer treatment		Approximately 45 months
Primary	Proportion of patients receiving chemotherapy as anti-cancer treatment		Approximately 45 months
Primary	Proportion of patients receiving targeted therapy as anti-cancer treatment		Approximately 45 months
Primary	Proportion of patients receiving supportive care as anti-cancer treatment		Approximately 45 months
Primary	Distribution of Treatment History in Head and Neck Cancer (HNC) patients		Approximately 45 months
Secondary	Distribution of overall survival (OS) by age		Approximately 45 months
Secondary	Distribution of overall survival (OS) by gender		Approximately 45 months
Secondary	Distribution of overall survival (OS) by stage		Approximately 45 months
Secondary	Distribution of overall survival (OS) by tumor site		Approximately 45 months
Secondary	Distribution of overall survival (OS) by treatment regimen		Approximately 45 months
Secondary	Number of treatment-limiting adverse events (AEs)	Incidence of important treatment-limiting adverse events (AEs) associated with systemic therapies	Approximately 45 months
Secondary	Number of withdrawals due to AEs		Approximately 45 months
Secondary	Proportion of diagnosis of another malignancy on or before the initial diagnosis of HNC		At Baseline

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls