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Head and Neck Cancer Registry (LORHAN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01080313
First received: March 2, 2010
Last updated: February 10, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention
Head and Neck Cancer
 Other: Therapy for head and neck cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective, Longitudinal, Multi-Center, Descriptive Registry of Patients Receiving Therapy Other Than Surgical Resection Alone for Newly Diagnosed Head and Neck Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Patterns of care for head and neck cancer [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival by treatment regimen [ Time Frame: study entry to death from any cause or to end of study ] [ Designated as safety issue: No ]
  • Determine the incidence and severity of major dose-limiting and other important treatment toxicities [ Time Frame: up to 10 years ] [ Designated as safety issue: Yes ]
  • Identify supportive care received for managing nutrition, pain, nausea and other complications [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
  • tumor control by treatment regimen [ Time Frame: study entry to progressive disease ] [ Designated as safety issue: No ]

Estimated Enrollment: 26000
Study Start Date: August 2005
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080313

Locations
United States, Minnesota
Mednet Solutions
Minnetonka, Minnesota, United States, 55305
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Mednet Solutions Mednet Solutions
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01080313     History of Changes
Other Study ID Numbers: 13440, I4E-US-S003
Study First Received: March 2, 2010
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013