Head and Neck Cancer Registry (LORHAN) (LORHAN)

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

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

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: Therapy for head and neck cancer

• Study Type: Observational
• Enrollment (Anticipated): 26000

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minnetonka, Minnesota, United States, 55305
      • Mednet Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with head and neck cancer	Other: Therapy for head and neck cancer; radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patterns of care for head and neck cancer	up to 10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival by treatment regimen	study entry to death from any cause or to end of study
Determine the incidence and severity of major dose-limiting and other important treatment toxicities	up to 10 years
Identify supportive care received for managing nutrition, pain, nausea and other complications	up to 10 years
tumor control by treatment regimen	study entry to progressive disease

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Mednet Solutions, Mednet Solutions

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: March 2, 2010
• First Submitted That Met QC Criteria: March 2, 2010
• First Posted (Estimate): March 4, 2010

Study Record Updates

• Last Update Posted (Estimate): February 13, 2012
• Last Update Submitted That Met QC Criteria: February 10, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 13440; I4E-US-S003 (Other Identifier: Eli Lilly and Company)