Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic	Completed	18 to 70	NCI	NYU-9917 NCI-G01-1915, NCT00012168

Objectives

1. 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.
2. Determine evidence of micrometastases in histologically normal sentinel lymph nodes resected from these patients.
3. Assess the clinical significance of micrometastases in lymph nodes resected from these patients.

Entry 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

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

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

Expected Enrollment

Approximately 25 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

NYU Cancer Institute at New York University Medical Center

Moni Kuriakose, MD, Protocol chair		Ph: 212-998-9564 Email: mak12@nyu.edu

Registry Information
Official Title		Lymphoscintigraphy Assisted Molecular Staging of Head and Neck Cancer
Trial Start Date		1999-05-17
Registered in ClinicalTrials.gov		NCT00012168
Date Submitted to PDQ		2001-01-10
Information Last Verified		2004-01-28
NCI Grant/Contract Number		P30-CA16087