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

Completed

• Conditions: Head & Neck Cancer
• Interventions: Other: Non-Interventional

• Registration Number: NCT03157674
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-24
• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Primary Completion: 2018-12-05
• Study Completion: 2020-04-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43994

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HNC patients	Non-Interventional	HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016.

Primary Outcome Measures

Name	Time	Method
Proportion of patients receiving radiotherapy as anti-cancer treatment	Approximately 45 months
Proportion of patients receiving supportive care as anti-cancer treatment	Approximately 45 months
Proportion of patients receiving chemotherapy as anti-cancer treatment	Approximately 45 months
Proportion of patients receiving surgery as anti-cancer treatment	Approximately 45 months
Proportion of patients receiving targeted therapy as anti-cancer treatment	Approximately 45 months
Distribution of Treatment History in Head and Neck Cancer (HNC) patients	Approximately 45 months

Secondary Outcome Measures

Name	Time	Method
Distribution of overall survival (OS) by age	Approximately 45 months
Distribution of overall survival (OS) by treatment regimen	Approximately 45 months
Number of withdrawals due to AEs	Approximately 45 months
Distribution of overall survival (OS) by gender	Approximately 45 months
Distribution of overall survival (OS) by stage	Approximately 45 months
Distribution of overall survival (OS) by tumor site	Approximately 45 months
Proportion of diagnosis of another malignancy on or before the initial diagnosis of HNC	At Baseline
Number of treatment-limiting adverse events (AEs)	Approximately 45 months	Incidence of important treatment-limiting adverse events (AEs) associated with systemic therapies

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Tokyo, Shibuya-ku, Japan