Carcinoma
Conditions
Keywords
carcinoma, upper, aerodigestive, tract, submandibular, gland
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREneck dissection of at least the ipsilateral sub-level 1B
neck dissection of at least the ipsilateral sub-level 1B
Sponsors
Southern Illinois University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Post Surgical Time point | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread. | Post surgical time point | Pathological detection of carcinoma within each of the dissected nodes reported as node groups. |
Countries
United States
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| Surgery A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Paperwork not completed in time | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Surgery |
|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 10.8 |
| Age, Customized <=18 years | 0 participants |
| Age, Customized >=80 years | 0 participants |
| Age, Customized Between 18 and 79 years | 22 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 14 Participants |
| sublevel IB dissection Not completed | 3 participants |
| sublevel IB dissection Surgery | 19 participants |
| submandibular gland excision Not completed | 3 participants |
| submandibular gland excision Surgery | 19 participants |
| surgical bed inspection Not completed | 3 participants |
| surgical bed inspection Surgery | 19 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
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.
Time frame: Post Surgical Time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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
The Presence or Absence of Carcinoma Within Each of the Assessed Nodes Will be Documented, as Well as Extracapsular Spread.
Pathological detection of carcinoma within each of the dissected nodes reported as node groups.
Time frame: Post surgical time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |
| Surgical Lymph Node Groups | 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 |