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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03157674
• Collaborator: Ono Pharmaceutical Co. Ltd (Industry)
• Enrollment: 43,994
• Location: 1
• Anticipated Duration (Months): 25.2
• Patients Per Site Per Month: 1745.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Head & Neck Cancer	Other: Non-Interventional

Study Design

• Study Type: Observational
• Actual Enrollment: 43994 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Real-World Evidence and Treatment Patterns: Head and Neck Cancer
• Actual Study Start Date: Nov 24, 2016
• Anticipated Primary Completion Date: Dec 31, 2018
• Anticipated Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
HNC patients HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016.	Other: Non-Interventional; Non-Interventional

Outcome Measures

Primary Outcome Measures

1. Proportion of patients receiving radiotherapy as anti-cancer treatment [Approximately 45 months]

2. Proportion of patients receiving surgery as anti-cancer treatment [Approximately 45 months]

3. Proportion of patients receiving chemotherapy as anti-cancer treatment [Approximately 45 months]

4. Proportion of patients receiving targeted therapy as anti-cancer treatment [Approximately 45 months]

5. Proportion of patients receiving supportive care as anti-cancer treatment [Approximately 45 months]

6. Distribution of Treatment History in Head and Neck Cancer (HNC) patients [Approximately 45 months]

Secondary Outcome Measures

1. Distribution of overall survival (OS) by age [Approximately 45 months]

2. Distribution of overall survival (OS) by gender [Approximately 45 months]

3. Distribution of overall survival (OS) by stage [Approximately 45 months]

4. Distribution of overall survival (OS) by tumor site [Approximately 45 months]

5. Distribution of overall survival (OS) by treatment regimen [Approximately 45 months]

6. Number of treatment-limiting adverse events (AEs) [Approximately 45 months]

   Incidence of important treatment-limiting adverse events (AEs) associated with systemic therapies

7. Number of withdrawals due to AEs [Approximately 45 months]

8. Proportion of diagnosis of another malignancy on or before the initial diagnosis of HNC [At Baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Tokyo	Shibuya-ku	Japan	150-0002

Sponsors and Collaborators

• Bristol-Myers Squibb
• Ono Pharmaceutical Co. Ltd

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03157674
• Other Study ID Numbers: CA209-868
• First Posted: May 17, 2017
• Last Update Posted: Jul 9, 2018
• Last Verified: Jul 1, 2018

• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Jul 9, 2018