CarcinomaPhase 1NCT00728130
Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients
A Phase 1 study testing neck dissection of at least the ipsilateral sub-level 1B in people with Carcinoma, run by Southern Illinois University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma
- What is being tested?
- neck dissection of at least the ipsilateral sub-level 1B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- 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.
- 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.
Read the detailed description
Hypothesis
- 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.
- All the lymph nodes in the submandibular triangle can be removed without resection of the submandibular gland.
Study Design
- A prospective controlled study.
- 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.
- 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.
- Conditions
- Carcinoma
- Being tested
- neck dissection of at least the ipsilateral sub-level 1B
- Keywords
- carcinoma, upper, aerodigestive, tract, submandibular, gland
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neck dissection of at least the ipsilateral sub-level 1BProcedure or surgery
Also called Lymphazurin®
neck dissection of at least the ipsilateral sub-level 1B
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | A neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients Receives: Procedure: neck dissection of at least the ipsilateral sub-level 1B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Pathological detection of carcinoma within each of the dissected nodes reported as node groups.
Measured: Post surgical time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Robbins, M.D., Principal investigator, SIU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728130
- Sponsor's protocol ID
- RON-SCCI 08-003-1
- Status last verified
- Dec 2014
- First submitted
- 31 Jul 2008
- Last updated
- 5 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 12117328
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00728130
- Acronym / sponsor ID
- RON-SCCI 08-003-1
- Conditions
- Carcinoma
- Keywords
- carcinoma, upper, aerodigestive, tract, submandibular, gland
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Aug 2008 (estimated)
- Results
- Posted 29 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis
- 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.
- 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
- 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.
- All the lymph nodes in the submandibular triangle can be removed without resection of the submandibular gland.
Study Design
- A prospective controlled study.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: neck dissection of at least the ipsilateral sub-level 1BA neck dissection of at least the ipsilateral sub-level 1B will be performed in all patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neck dissection of at least the ipsilateral sub-level 1BAlso: Lymphazurin®neck dissection of at least the ipsilateral sub-level 1B | Procedure or surgery | A |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12117328Robbins 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.
- sponsoring institution websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Robbins, M.D. principal investigator
SIU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing neck dissection of at least the ipsilateral sub-level 1B in people with Carcinoma, run by Southern Illinois University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00728130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2015.