Head and Neck Cancer Registry (LORHAN)

Head and Neck Cancer Clinical Trial

— LORHAN  

Official title:

Prospective, Longitudinal, Multi-Center, Descriptive Registry of Patients Receiving Therapy Other Than Surgical Resection Alone for Newly Diagnosed Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080313
• Other study ID #: 13440
• Secondary ID: I4E-US-S003
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: February 10, 2012
• Start date: August 2005
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to describe, in detail, patterns of care for head and neck carcinoma patient

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26000
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathologically (histologically or cytologically) confirmed new diagnosis of carcinoma involving the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or neck node metastasis from unknown origin

• Scheduled to receive radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy

• Written informed consent

Exclusion Criteria:

• Registry participation does not exclude participation in clinical trials.

• Patients scheduled to receive or who have received surgery are eligible for Registry participation as long as they are also scheduled to receive medical therapy.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Therapy for head and neck cancer
radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy

Locations

Country	Name	City	State
United States	Mednet Solutions	Minnetonka	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patterns of care for head and neck cancer		up to 10 years	No
Secondary	Overall survival by treatment regimen		study entry to death from any cause or to end of study	No
Secondary	Determine the incidence and severity of major dose-limiting and other important treatment toxicities		up to 10 years	Yes
Secondary	Identify supportive care received for managing nutrition, pain, nausea and other complications		up to 10 years	No
Secondary	tumor control by treatment regimen		study entry to progressive disease	No