Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients

Carcinoma Clinical Trial

Official title:

Prospective Study to Assess the Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Patients With Carcinoma of the Upper Aerodigestive Tract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728130
• Other study ID #: RON-SCCI 08-003-1
• Status: Completed
• Phase: Phase 1
• First received: July 31, 2008
• Last updated: December 12, 2014
• Start date: May 2008
• Est. completion date: June 2010

Study information

• Verified date: December 2014
• Source: Southern Illinois University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

2. All the lymph nodes in the submandibular triangle can be removed without resection of the submandibular gland.

Study Design

1. A prospective controlled study.

2. A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. In case of oral cavity tumors, about 15 minutes prior to the surgery, 1ml of Lymphazurin® blue dye will be injected in 4 quadrants around the primary site. The dissection will be performed in 3 stages. In the first stage all lymph node groups that lie either lateral, anterior, posterior, superior, or inferior to the submandibular gland, but within anatomical boundaries of level 1B, will be dissected. The submandibular gland will be left intact for this portion of the procedure. Next, the submandibular gland will be removed. Lastly, any remaining fibrofatty tissue that lies deep to the submandibular gland within the confines of level IB will be removed. Each lymph node group, the submandibular gland, and the fibrofatty tissue lying deep to the submandibular gland, will be submitted for pathological assessment in separate containers.

3. The following end-points will be measured: the number of lymph nodes identified within each lymph node group, the number of lymph nodes located within the submandibular gland, and the number of lymph nodes within the fibrofatty contents lying deep to the submandibular gland. The presence or absence of carcinoma within each of the assessed nodes will be documented, as well as extracapsular spread.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma

Intervention

Procedure:
• neck dissection of at least the ipsilateral sub-level 1B
neck dissection of at least the ipsilateral sub-level 1B

Locations

Country	Name	City	State
United States	SIU School of Medicine	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Southern Illinois University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Robbins KT, Clayman G, Levine PA, Medina J, Sessions R, Shaha A, Som P, Wolf GT; American Head and Neck Society; American Academy of Otolaryngology--Head and Neck Surgery. Neck dissection classification update: revisions proposed by the American Head and Neck Society and the American Academy of Otolaryngology-Head and Neck Surgery. Arch Otolaryngol Head Neck Surg. 2002 Jul;128(7):751-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	The number of head/ neck lymph nodes in pre-defined groups: Preglandular, Prevascular, Retrovascular, and Retroglandular as well as the number of nodes within the submandibular gland and within the fibrofatty contents lying deep to the submandibular gland.	Post Surgical Time point	No
Secondary	The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.	Pathological detection of carcinoma within each of the dissected nodes reported as node groups.	Post surgical time point	No

External Links

•   sponsoring institution website