Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Carcinoma

Thank you

Trial Information

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

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.


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
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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Thomas Robbins, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

SIU School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

RON-SCCI 08-003-1

NCT ID:

NCT00728130

Start Date:

May 2008

Completion Date:

June 2010

Related Keywords:

  • Carcinoma
  • carcinoma
  • upper
  • aerodigestive
  • tract
  • submandibular
  • gland
  • Carcinoma

Name

Location

SIU School of MedicineSpringfield, Illinois  62702