Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck

NCT00002695 | Completed

• 2 other identifiers: CDR0000064467E-4393
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Diagnostic procedures, such as analysis of tumor tissue and lymph nodes that have been surgically removed, may improve the treatment of patients with cancers of the head and neck. PURPOSE: Diagnostic trial to determine if analyzing tumor tissue and lymph nodes surgically removed from patients with cancers of the head and neck can predict recurrence of the cancer.

Conditions

Head and Neck Cancer

Keywords

stage I squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; stage I squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the paranasal sinus and nasal cavity; stage II squamous cell carcinoma of the paranasal sinus and nasal cavity; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Interventions

DNA stability analysis GENETIC

microsatellite instability analysis GENETIC

mutation analysis GENETIC

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of squamous cell carcinoma of the upper aerodigestive tract (excluding the nasopharynx) for which curative resection is scheduled * Recurrent disease allowed if resectable * Patients with clinically and histologically proven stage N0-1 neck disease who are undergoing dissection are eligible for analysis of occult nodal disease * No distant metastasis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other malignancy within the past 5 years except nonmelanomatous skin cancer or lymphoma PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior limited chemotherapy to the index lesion allowed Endocrine therapy: * Not specified Radiotherapy: * Prior limited radiotherapy to the index lesion allowed Surgery: * See Disease Characteristics * Prior limited surgery to the index lesion allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

CCOP - Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Related Publications (4)

• Koch WM, Ridge JA, Forastiere A, Manola J. Comparison of clinical and pathological staging in head and neck squamous cell carcinoma: results from Intergroup Study ECOG 4393/RTOG 9614. Arch Otolaryngol Head Neck Surg. 2009 Sep;135(9):851-8. doi: 10.1001/archoto.2009.123.

  PMID: 19770416 RESULT

• Westra WH, Taube JM, Poeta ML, Begum S, Sidransky D, Koch WM. Inverse relationship between human papillomavirus-16 infection and disruptive p53 gene mutations in squamous cell carcinoma of the head and neck. Clin Cancer Res. 2008 Jan 15;14(2):366-9. doi: 10.1158/1078-0432.CCR-07-1402.

  PMID: 18223210 RESULT

• Poeta ML, Manola J, Goldwasser MA, Forastiere A, Benoit N, Califano JA, Ridge JA, Goodwin J, Kenady D, Saunders J, Westra W, Sidransky D, Koch WM. TP53 mutations and survival in squamous-cell carcinoma of the head and neck. N Engl J Med. 2007 Dec 20;357(25):2552-61. doi: 10.1056/NEJMoa073770.

  PMID: 18094376 RESULT

• Poeta LM, Goldwasser MA, Forastiere A, et al.: Prognostic implication of p53 mutations in HNSCC: results of intragroup margin study (E4393). [Abstract] J Clin Oncol 24 (Suppl 18): A-5504, 2006.

  RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Wayne M. Koch, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 11, 2003
• Study Start: April 30, 1996
• Primary Completion: October 18, 2002
• Study Completion: May 27, 2011
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (4)