Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
K. Thomas Robbins, MD, Southern Illinois University
ClinicalTrials.gov Identifier:
NCT00728130
First received: July 31, 2008
Last updated: May 29, 2013
Last verified: May 2013

July 31, 2008
May 29, 2013
May 2008
January 2010   (final data collection date for primary 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. [ Time Frame: Post Surgical Time point ] [ Designated as safety issue: No ]
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.
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: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00728130 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Pathological detection of carcinoma within each of the dissected nodes reported as node groups.
The presence or absence of carcinoma within each of the assessed nodes will be documented, as well as extracapsular spread. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients
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.

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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma
Procedure: neck dissection of at least the ipsilateral sub-level 1B
neck dissection of at least the ipsilateral sub-level 1B
Other Name: Lymphazurin®
Experimental: A
A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients
Intervention: Procedure: neck dissection of at least the ipsilateral sub-level 1B
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. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
June 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00728130
RON-SCCI 08-003-1
No
K. Thomas Robbins, MD, Southern Illinois University
Southern Illinois University
Not Provided
Principal Investigator: Thomas Robbins, M.D. SIU School of Medicine
Southern Illinois University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP