Phase 1
N=22
Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients
Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00728130 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: the Number of Lymph Nodes: 1. Identified Within Each Lymph Node Group, 2.Located Within the Submandibular Gland, and 3. Within the Fibrofatty Contents Lying Deep to the Submandibular Gland. — 2.3; 1.1; 1.0; 1.1 nodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- neck dissection of at least the ipsilateral sub-level 1B (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Southern Illinois University
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Number of Lymph Nodes: 1. Identified Within Each Lymph Node Group, 2.Located Within the Submandibular Gland, and 3. Within the Fibrofatty Contents Lying Deep to the Submandibular Gland. |
2.3; 1.1; 1.0; 1.1; 1.5; 2.3 | — |
| SECONDARY The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread. |
0; 0.1; 0; 0; 0.2; 0.3 | — |
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.
2. All the lymph nodes in the submandibular triangle can be removed without resection of the submandibular gland.
Study Design
A better understanding of the frequency of submandibular gland involvement may lead to refined treatment strategies for head and neck cancer, which can possibly spare removal of the submandibular gland and potentially improve the long term side effects from therapy.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00728130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.