NCT00728130

Brief Summary

Hypothesis

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

July 29, 2013

Completed
Last Updated

January 5, 2015

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

July 31, 2008

Results QC Date

May 29, 2013

Last Update Submit

December 12, 2014

Conditions

Carcinoma

Keywords

carcinomaupperaerodigestivetractsubmandibulargland

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.

    Post surgical time point

Study Arms (1)

A

EXPERIMENTAL

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

Interventions

neck dissection of at least the ipsilateral sub-level 1BPROCEDURE

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

Also known as: Lymphazurin®
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SIU School of Medicine

Springfield, Illinois, 62702, United States

Location

Related 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. doi: 10.1001/archotol.128.7.751. No abstract available.

    PMID: 12117328BACKGROUND

Related Links

MeSH Terms

Conditions

Carcinoma

Interventions

iso-sulfan blue

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Results Point of Contact

Title
Director of Clinical Trials
Organization
Simmons Cancer Institute at Southern Illinois University School of Medicine
krobinson@siumed.edu
217-545-1946

Study Officials

  • Thomas Robbins, M.D.

    SIU School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 5, 2008

Study Start

May 1, 2008

Primary Completion

January 1, 2010

Study Completion

June 1, 2010

Last Updated

January 5, 2015

Results First Posted

July 29, 2013

Record last verified: 2014-12

Locations

US(1)