Head and Neck CancerNCT00042926
Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
A study testing immunohistochemistry staining method, conventional surgery and lymphangiography in people with Head and Neck Cancer, run by Alliance for Clinical Trials in Oncology.
Trial summary
RATIONALE: Diagnostic procedures to detect cancer cells in sentinel lymph nodes may help plan effective cancer treatment. PURPOSE: Diagnostic trial to study the effectiveness of lymph node mapping and sentinel lymph node lymphadenectomy in patients who are undergoing surgery to remove early-stage cancer of the mouth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- immunohistochemistry staining method, conventional surgery and lymphangiography
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient must be > 18 years of age.
- Patient must have an ECOG/Zubrod performance status of < 2.
- Patient must have a histologically confirmed primary T1 or T2 invasive OCSCCA that is > 6mm and < 4 cm in size. The primary tumor must be amenable to curative resection and must be diagnosed within 42 days prior to surgery.
- Patient must be clinically stage N0 confirmed with a negative imaging study employing contrastenhanced CT scan (or MRI with gadolinium in patients with iodine allergy). Lymph nodes will be considered positive if:
- Greater than 1.5 cm in size for levels I and II.
- Greater than 1 cm in size for levels III, IV, V and VI.
Show all 16Show fewer
- If any lymph node exhibits central necrosis, irregular enhancement of a poorly defined or irregular capsular border.
- Groups of three or more asymmetrically located LNs, with a minimal axial diameter of 8 mm or more, in the suspected tumor drainage area are present.
- NOTE: All CT scans must be read by a neuroradiologist.
- Patient must be medically fit for neck dissection.
- Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration or any study-related procedures.
- Female patient of childbearing potential must have negative serum pregnancy test within 30 daysprior to registration.
- If the patient is a survivor of a prior cancer, ALL of the following criteria are met:
- Patient has undergone potentially curative therapy for all prior malignancies,
- No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone),
- Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
Who cannot join
- Patient received prior treatment to the cervical lymph nodes, including surgery or radiation therapy.
- Patient experienced prior extensive trauma to the anterior cervical region of the neck.
- Patient has lesions that cross the vermilion border involving lip skin.
- Patient has had previous tumor resection involving the neck.
- Patient has had injections of radioactive material for previous scans within 48 hours of the radiolymphoscintigraphy.
About this study
Official title: A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma
RATIONALE: Diagnostic procedures to detect cancer cells in sentinel lymph nodes may help plan effective cancer treatment.
PURPOSE: Diagnostic trial to study the effectiveness of lymph node mapping and sentinel lymph node lymphadenectomy in patients who are undergoing surgery to remove early-stage cancer of the mouth.
Read the detailed description
OBJECTIVES:
- Determine whether a negative hematoxylin and eosin finding from the lymphatic mapping and sentinel node lymphadenectomy procedure accurately predicts the negativity of the other cervical lymph nodes in patients with stage I or II squamous cell carcinoma of the oral cavity.
- Determine the extent and pattern of disease spread in the nodal bed in these patients.
- Obtain data on the use of immunohistochemistry to assess nodes in these patients.
- Conditions
- Head and Neck Cancer
- Being tested
- immunohistochemistry staining method, conventional surgery, lymphangiography, radionuclide imaging, sentinel lymph node biopsy
- Keywords
- stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
lymphangiographyProcedure or surgery
radionuclide imagingProcedure or surgery
sentinel lymph node biopsyProcedure or surgery
technetium Tc 99m sulfur colloidRadiation
| Study group | Role | What they receive |
|---|---|---|
| Radiolymphoscintigraphy + surgery | Experimental | Patients undergo radiolymphoscintigraphy comprising technetium Tc 99m sulfur colloid to identify the sentinel lymph nodes (SNL). Within 18 hours after radiolymphoscintigraphy, patients undergo resection of the primary oral cavity tumor and radioguided sentinel lymphadenectomy and regional cervical lymphadenectomy. Lymph nodes are examined by hematoxylin and eosin (H\&E) staining. If negative by H\&E, lymph nodes are further analyzed by immunohistochemistry.
Patients are followed at 30 days. Receives: Other: immunohistochemistry staining method; Procedure: conventional surgery; Procedure: lymphangiography; Procedure: radionuclide imaging; Procedure: sentinel lymph node biopsy; Radiation: technetium Tc 99m sulfur colloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of non-SLN(s) negative patients
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 2002
- Primary completionMay 2007
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Francisco Civantos, MD, Study chair, University of Miami Sylvester Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042926
- Sponsor's protocol ID
- ACOSOG-Z0360
- Other IDs
- CDR0000069485
- Status last verified
- Dec 2016
- First submitted
- 5 Aug 2002
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Civantos FJ, Zitsch RP, Schuller DE, Agrawal A, Smith RB, Nason R, Petruzelli G, Gourin CG, Wong RJ, Ferris RL, El Naggar A, Ridge JA, Paniello RC, Owzar K, McCall L, Chepeha DB, Yarbrough WG, Myers JN. Sentinel lymph node biopsy accurately stages the regional lymph nodes for T1-T2 oral squamous cell carcinomas: results of a prospective multi-institutional trial. J Clin Oncol. 2010 Mar 10;28(8):1395-400. doi: 10.1200/JCO.2008.20.8777. Epub 2010 Feb 8.
PubMed 20142602
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00042926
- Acronym / sponsor ID
- ACOSOG-Z0360
- Conditions
- Head and Neck Cancer
- Keywords
- stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2002
- Primary completion
- May 2007 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Diagnostic procedures to detect cancer cells in sentinel lymph nodes may help plan effective cancer treatment.
PURPOSE: Diagnostic trial to study the effectiveness of lymph node mapping and sentinel lymph node lymphadenectomy in patients who are undergoing surgery to remove early-stage cancer of the mouth.
Detailed description
OBJECTIVES:
- Determine whether a negative hematoxylin and eosin finding from the lymphatic mapping and sentinel node lymphadenectomy procedure accurately predicts the negativity of the other cervical lymph nodes in patients with stage I or II squamous cell carcinoma of the oral cavity.
- Determine the extent and pattern of disease spread in the nodal bed in these patients.
- Obtain data on the use of immunohistochemistry to assess nodes in these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiolymphoscintigraphy + surgery | Experimental | Other: immunohistochemistry staining method, Procedure: conventional surgery, Procedure: lymphangiography, Procedure: radionuclide imaging, Procedure: sentinel lymph node biopsy, Radiation: technetium Tc 99m sulfur colloidPatients undergo radiolymphoscintigraphy comprising technetium Tc 99m sulfur colloid to identify the sentinel lymph nodes (SNL). Within 18 hours after radiolymphoscintigraphy, patients undergo resection of the primary oral cavity tumor and radioguided sentinel lymphadenectomy and regional cervical lymphadenectomy. Lymph nodes are examined by hematoxylin and eosin (H\&E) staining. If negative by H\&E, lymph nodes are further analyzed by immunohistochemistry. Patients are followed at 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient must be > 18 years of age.
- Patient must have an ECOG/Zubrod performance status of < 2.
- Patient must have a histologically confirmed primary T1 or T2 invasive OCSCCA that is > 6mm and < 4 cm in size. The primary tumor must be amenable to curative resection and must be diagnosed within 42 days prior to surgery.
- Patient must be clinically stage N0 confirmed with a negative imaging study employing contrastenhanced CT scan (or MRI with gadolinium in patients with iodine allergy). Lymph nodes will be considered positive if:
- Patient must be medically fit for neck dissection.
Key exclusion criteria (5 listed)
- Patient received prior treatment to the cervical lymph nodes, including surgery or radiation therapy.
- Patient experienced prior extensive trauma to the anterior cervical region of the neck.
- Patient has lesions that cross the vermilion border involving lip skin.
- Patient has had previous tumor resection involving the neck.
- Patient has had injections of radioactive material for previous scans within 48 hours of the radiolymphoscintigraphy.
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 |
|---|---|---|
| immunohistochemistry staining method | Other | Radiolymphoscintigraphy + surgery |
| conventional surgery | Procedure or surgery | Radiolymphoscintigraphy + surgery |
| lymphangiography | Procedure or surgery | Radiolymphoscintigraphy + surgery |
| radionuclide imaging | Procedure or surgery | Radiolymphoscintigraphy + surgery |
| sentinel lymph node biopsy | Procedure or surgery | Radiolymphoscintigraphy + surgery |
| technetium Tc 99m sulfur colloid | Radiation | Radiolymphoscintigraphy + surgery |
Primary outcome
Proportion of non-SLN(s) negative patients
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Results publication: PubMed 20142602Civantos FJ, Zitsch RP, Schuller DE, Agrawal A, Smith RB, Nason R, Petruzelli G, Gourin CG, Wong RJ, Ferris RL, El Naggar A, Ridge JA, Paniello RC, Owzar K, McCall L, Chepeha DB, Yarbrough WG, Myers JN. Sentinel lymph node biopsy accurately stages the regional lymph nodes for T1-T2 oral squamous cell carcinomas: results of a prospective multi-institutional trial. J Clin Oncol. 2010 Mar 10;28(8):1395-400. doi: 10.1200/JCO.2008.20.8777. Epub 2010 Feb 8.
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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.
Francisco Civantos, MD study chair
University of Miami Sylvester Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing immunohistochemistry staining method, conventional surgery and lymphangiography in people with Head and Neck Cancer, run by Alliance for Clinical Trials in Oncology.
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 16 inclusion and 5 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 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of non-SLN(s) negative patients (time frame: Up to 30 days). 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 NCT00042926, 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 7 Dec 2016; AzTrials last refreshed its copy on 7 Nov 2026.