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Lymphoscintigraphy Assisted Molecular Staging of Head and Neck Cancer


N/A
18 Years
70 Years
Not Enrolling
Both
Head and Neck Cancer

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Trial Information

Lymphoscintigraphy Assisted Molecular Staging of Head and Neck Cancer


OBJECTIVES:

- Evaluate the sensitivity of lymphoscintigraphy and isosulfan blue in localization of
sentinel lymph nodes in patients with previously untreated squamous cell carcinoma of
the oral cavity or oropharynx.

- Determine evidence of micrometastases in histologically normal sentinel lymph nodes
resected from these patients.

- Assess the clinical significance of micrometastases in lymph nodes resected from these
patients.

OUTLINE: Patients undergo preoperative lymphoscintigraphy utilizing technetium Tc 99m sulfur
colloid followed by intraoperative injections of isosulfan blue at 3-4 locations into the
primary tumor periphery. Once the afferent lymphatic channel and sentinel node have been
identified, patients undergo cervical lymphadenectomy followed by resection of the primary
tumor.

Resected primary tumor, radioactive lymph nodes, and blue-stained sentinel nodes are then
subjected to molecular (polymerase chain reaction) and histocytochemical
(immunohistochemistry for cytokeratin and micrometastases, light microscopy) analyses.

Patients are followed at 1, 3, 6, 12, 18, and 24 months.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary squamous cell carcinoma of the oral cavity or
oropharynx

- Stage 0-IVA (Any T, N0)

- No low-risk tumors

- Must require elective staging neck dissection and resection of primary tumor

PATIENT CHARACTERISTICS:

Age:

- 18 to 70

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Not pregnant or nursing

- No concurrent impaired mental status

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy

Surgery:

- See Disease Characteristics

- No prior surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Moni A. Kuriakose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000068489

NCT ID:

NCT00012168

Start Date:

May 1999

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage 0 oropharyngeal cancer
  • stage 0 lip and oral cavity cancer
  • 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
  • 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
  • Head and Neck Neoplasms
  • Mouth Neoplasms

Name

Location

NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016