Status:
COMPLETED
Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients
Lead Sponsor:
Southern Illinois University
Conditions:
Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Hypothesis 1. The submandibular gland is not a lymphatic organ and usually remains uninvolved with head and neck cancer despite the presence of metastatic disease in the lymph nodes that surround it....
Detailed Description
Hypothesis 1. The submandibular gland is not a lymphatic organ and usually remains uninvolved with head and neck cancer despite the presence of metastatic disease in the lymph nodes that surround it....
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
- Treatment of the regional lymph nodes to include neck dissection performed as the primary modality
- No previous treatment to the neck
- No previous treatment for the index cancer (surgery, chemotherapy, radiation or biological therapy)
- No known distant metastatic disease
- Age \>/= 18
- The ability to understand and willingness to sign a study-specific written informed consent form
- Protocol treatment must begin \</= 8 weeks of diagnostic biopsy
Exclusion
- Previous or concurrent head and neck primaries
- Prior surgery to study site other than biopsy
- Patients receiving any other treatment for cancer within 30 days previously
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements
- Known allergy to Lymphazurin®
- Pregnant or breast feeding females
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00728130
Start Date
May 1 2008
End Date
June 1 2010
Last Update
January 5 2015
Active Locations (1)
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1
SIU School of Medicine
Springfield, Illinois, United States, 62702