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

December 12, 2014 updated by: Southern Illinois University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.
  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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Springfield, Illinois, United States, 62702
        • SIU School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients
Procedure: neck dissection of at least the ipsilateral sub-level 1B
neck dissection of at least the ipsilateral sub-level 1B
Other Names:
  • Lymphazurin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Post Surgical Time point
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.
Time Frame: Post surgical time point
Pathological detection of carcinoma within each of the dissected nodes reported as node groups.
Post surgical time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Illinois University

Investigators

  • Principal Investigator: Thomas Robbins, M.D., SIU School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

July 31, 2008

First Submitted That Met QC Criteria

August 4, 2008

First Posted (ESTIMATE)

August 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 5, 2015

Last Update Submitted That Met QC Criteria

December 12, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RON-SCCI 08-003-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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