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Home > "L" Clinical Trials Conditions > Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat  Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat
Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat
For Condition: lip and oral cavity cancer,Oropharyngeal Cancer
Status: Completed
Sponsor(s): Kaplan Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: New imaging procedures such as lymphoscintigraphy may improve the ability to detect the spread of mouth and throat cancer to lymph nodes in the neck. PURPOSE: Pilot study of lymphoscintigraphy followed by sentinel lymph node mapping and sentinel lymph node biopsy to detect lymph node metastases in the neck in patients who have mouth or throat cancer.
Details: 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.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AbrahamKuriakose, Study Chair, Kaplan Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: CDR0000068489; NYU-9917,NCI-G01-1915
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012168
Other Oropharyngeal Cancer Studies:
1. Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer
2. Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Head and Neck
3. RK-0202 in Preventing Oral Mucositis in Patients Who are Undergoing Radiation Therapy for Cancer of the Mouth, Throat, or Salivary Glands
4. Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
5. Oxaliplatin in Treating Patients With Advanced Head and Neck Cancer
Related Studies:
Other Oropharyngeal Cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat
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