Trial Outcomes & Findings for Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients (NCT NCT00728130)
NCT ID: NCT00728130
Last Updated: 2015-01-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Post Surgical Time point
Results posted on
2015-01-05
Participant Flow
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
Participant milestones
| Measure |
Surgery
A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Surgery
A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Paperwork not completed in time
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients
Baseline characteristics by cohort
| Measure |
Surgery
n=22 Participants
A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients.
|
|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Age, Customized
<=18 years
|
0 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 79 years
|
22 participants
n=5 Participants
|
|
Age, Customized
>=80 years
|
0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
submandibular gland excision
Surgery
|
19 participants
n=5 Participants
|
|
submandibular gland excision
Not completed
|
3 participants
n=5 Participants
|
|
sublevel IB dissection
Surgery
|
19 participants
n=5 Participants
|
|
sublevel IB dissection
Not completed
|
3 participants
n=5 Participants
|
|
surgical bed inspection
Surgery
|
19 participants
n=5 Participants
|
|
surgical bed inspection
Not completed
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post Surgical Time pointThe 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.
Outcome measures
| Measure |
Surgical Lymph Node Groups
n=19 Participants
A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. The number of nodes for each nodal groups will be reported.
|
|---|---|
|
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.
Preglandular nodal group-Right neck
|
2.3 nodes
Standard Deviation 1.4
|
|
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.
Prevascular nodal group-Right neck
|
1.1 nodes
Standard Deviation 0.8
|
|
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.
Retrovascular nodal group-Right neck
|
1.0 nodes
Standard Deviation 1.3
|
|
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.
Retroglandular nodal group-Right neck
|
1.1 nodes
Standard Deviation 1.1
|
|
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.
Preglandular nodal group-Left neck
|
1.5 nodes
Standard Deviation 1.3
|
|
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.
Prevascular nodal group-Left neck
|
2.3 nodes
Standard Deviation 1.7
|
|
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.
Retrovascular nodal group-Left neck
|
1.4 nodes
Standard Deviation 1.5
|
|
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.
Retroglandular nodal group-Left neck
|
1.1 nodes
Standard Deviation 1.2
|
|
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.
Submandibular nodes (Right or Left)
|
0 nodes
Standard Deviation 0
|
|
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.
Nodes Deep to Submandibular gland (Right or Left)
|
0 nodes
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Post surgical time pointPathological detection of carcinoma within each of the dissected nodes reported as node groups.
Outcome measures
| Measure |
Surgical Lymph Node Groups
n=19 Participants
A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. The number of nodes for each nodal groups will be reported.
|
|---|---|
|
The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.
Retrovascular nodal positivity left neck
|
0 carcinoma positive nodes
Standard Deviation 0
|
|
The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.
Retroglandular nodal positivity left neck
|
0 carcinoma positive nodes
Standard Deviation 0
|
|
The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.
Preglandular nodal positivity right neck
|
0 carcinoma positive nodes
Standard Deviation 0
|
|
The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.
Prevascular nodal positivity right neck
|
0.1 carcinoma positive nodes
Standard Deviation 0.8
|
|
The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.
Retrovascular nodal positivity right neck
|
0 carcinoma positive nodes
Standard Deviation 0
|
|
The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.
Retroglandular nodal positivity right neck
|
0 carcinoma positive nodes
Standard Deviation 0
|
|
The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.
Preglandular nodal positivity left neck
|
0.2 carcinoma positive nodes
Standard Deviation 0.6
|
|
The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.
Prevascular nodal positivity left neck
|
0.3 carcinoma positive nodes
Standard Deviation 0.6
|
Adverse Events
Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Trials
Simmons Cancer Institute at Southern Illinois University School of Medicine
Phone: 217-545-1946
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place