Screening Trial to Study Eligibility of Patients to Participate in Head and Neck Surgery Clinical Trials - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00045071

Purpose

RATIONALE: Evaluating patients for eligibility in clinical trials may help doctors plan more effective surgery for patients who have cancer.

PURPOSE: This screening trial is determining the eligibility of patients to participate in head and neck surgery clinical trials at the National Institute on Deafness and Other Communication Disorders and National Cancer Institute.

Condition	Intervention
Head and Neck Cancer	Procedure: physiologic testing

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Non-Randomized, Active Control
Official Title:	Evaluation For NIDCD Head And Neck Surgery Branch Clinical Research Protocols

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Patient eligibility during screening [ Designated as safety issue: No ]
Permission of standard treatment in patients ineligible for a Head and Neck Surgery Branch (HNSB) protocol as assessed by clinical exam and imaging studies during screening [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	June 2002
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Evaluate eligibility of patients with neoplastic disease of the head and neck for clinical research protocols at the National Institute on Deafness and Other Communication Disorders Head and Neck Surgery Branch and National Cancer Institute.

OUTLINE: Patients undergo various diagnostic procedures and clinical testing to determine protocol eligibility. The procedures and testing may include, but are not limited to, laboratory blood tests, including HLA typing, hepatitis screening, and HIV serology; various nuclear medicine and imaging scans with or without contrast dye; pulmonary function tests; endoscopy; incisional or excisional biopsy; fine-needle aspiration; and arteriogram.

PROJECTED ACCRUAL: A maximum of 300 patients will be accrued for this study within 5 years.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed or suspected neoplastic disease of the head and neck with 1 of the following histological subtypes:
- Squamous cell carcinoma
- Verrucous carcinoma

PATIENT CHARACTERISTICS:

Age

Any age

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Concurrent chemotherapy allowed

Endocrine therapy

Not specified

Radiotherapy

Concurrent radiotherapy allowed

Surgery

No concurrent surgical procedure except those required by a screening test or biopsy on this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045071

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Carter Van Waes, MD, PhD

National Institute on Deafness and Other Communication Disorders (NIDCD)

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000256310, NCI-01-DC-0099
Study First Received:	September 6, 2002
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00045071
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

metastatic squamous neck cancer with occult primary squamous cell carcinoma
recurrent metastatic squamous neck cancer with occult primary
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent verrucous carcinoma of the larynx
recurrent verrucous carcinoma of the oral cavity
stage 0 hypopharyngeal cancer
stage 0 laryngeal cancer
stage 0 lip and oral cavity cancer
stage 0 nasopharyngeal cancer
stage 0 oropharyngeal cancer

stage 0 paranasal sinus and nasal cavity cancer
stage I squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage I squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the nasopharynx
stage I squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage I verrucous carcinoma of the larynx
stage I verrucous carcinoma of the oral cavity
stage II squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the nasopharynx
stage II squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity

Study placed in the following topic categories:

Squamous cell carcinoma
Laryngeal Neoplasms
Lip and oral cavity cancer
Recurrence
Carcinoma
Epidermoid carcinoma
Nasopharyngeal carcinoma

Head and Neck Neoplasms
Oral cancer
Metastatic squamous neck cancer with occult primary
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Carcinoma, Squamous Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009