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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03157674
Enrollment
43994
Registered
2017-05-17
Start date
2016-11-24
Completion date
2020-04-20
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head & Neck Cancer

Brief summary

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

Interventions

OTHERNon-Interventional

Non-Interventional

Sponsors

Ono Pharmaceutical Co. Ltd
CollaboratorINDUSTRY
Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Proportion of patients receiving radiotherapy as anti-cancer treatmentApproximately 45 months
Proportion of patients receiving surgery as anti-cancer treatmentApproximately 45 months
Proportion of patients receiving chemotherapy as anti-cancer treatmentApproximately 45 months
Proportion of patients receiving targeted therapy as anti-cancer treatmentApproximately 45 months
Proportion of patients receiving supportive care as anti-cancer treatmentApproximately 45 months
Distribution of Treatment History in Head and Neck Cancer (HNC) patientsApproximately 45 months

Secondary

MeasureTime frameDescription
Number of withdrawals due to AEsApproximately 45 months
Number of treatment-limiting adverse events (AEs)Approximately 45 monthsIncidence of important treatment-limiting adverse events (AEs) associated with systemic therapies
Proportion of diagnosis of another malignancy on or before the initial diagnosis of HNCAt Baseline
Distribution of overall survival (OS) by ageApproximately 45 months
Distribution of overall survival (OS) by genderApproximately 45 months
Distribution of overall survival (OS) by stageApproximately 45 months
Distribution of overall survival (OS) by tumor siteApproximately 45 months
Distribution of overall survival (OS) by treatment regimenApproximately 45 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026