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
Results First Received: May 29, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma
Intervention: Procedure: neck dissection of at least the ipsilateral sub-level 1B

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Treatment planning was performed for all patients in the multidisciplinary head and neck oncology forum before recruitment into the trial.

Dates of recruitment: 06/11/2008 through 09/17/2009 Number of patients recruited: 23 Number of patient completing trial: 20


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Surgery A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.

Participant Flow:   Overall Study
    Surgery  
STARTED     22  
COMPLETED     19  
NOT COMPLETED     3  
Withdrawal by Subject                 1  
Paperwork not completed in time                 1  
Physician Decision                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Surgery A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.

Baseline Measures
    Surgery  
Number of Participants  
[units: participants]
  22  
Age  
[units: years]
Mean ± Standard Deviation
  56.5  ± 10.8  
Age, Customized  
[units: participants]
 
<=18 years     0  
Between 18 and 79 years     22  
>=80 years     0  
Gender  
[units: participants]
 
Female     8  
Male     14  
submandibular gland excision  
[units: participants]
 
Surgery     19  
Not completed     3  
sublevel IB dissection  
[units: participants]
 
Surgery     19  
Not completed     3  
surgical bed inspection  
[units: participants]
 
Surgery     19  
Not completed     3  



  Outcome Measures
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1.  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.   [ Time Frame: Post Surgical Time point ]

2.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
none  


Results Point of Contact:  
Name/Title: Director of Clinical Trials
Organization: Simmons Cancer Institute at Southern Illinois University School of Medicine
phone: 217-545-1946
e-mail: krobinson@siumed.edu


Publications:

Responsible Party: K. Thomas Robbins, MD, Southern Illinois University
ClinicalTrials.gov Identifier: NCT00728130     History of Changes
Other Study ID Numbers: RON-SCCI 08-003-1
Study First Received: July 31, 2008
Results First Received: May 29, 2013
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board