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Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
Study Purpose
This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Inclusion Criteria:
- - Appropriate stage for study entry (T1-2N0M0; American Joint Committee on Cancer [AJCC]
8th edition [ed.
]) based on the following diagnostic workup:- - Imaging of chest within 42 days prior to registration; chest x-ray, CT chest
scan (with or without contrast) or PET/CT (with or without contrast)
- Surgical assessment within 42 days prior to registration.
Patient must be a candidate for surgical intervention with sentinel lymph node (SLN) biopsy and potential completion neck dissection (CND) or elective neck dissection (END)- - PRIOR TO STEP 2 RANDOMIZATION:
- FDG PET/CT required prior to step 2.
Note: FDG PET/CT done prior to step 1 can be submitted for central review.Exclusion Criteria:
- - Prior surgery involving the lateral neck, including neck dissection or gross injury to
the neck that would preclude surgical dissection for this trial.
Prior thyroid and central neck surgery is permissible; biopsy is permitted. Note: Borderline suspicious nodes that are ≥ 1 cm with radiographic finding suggestive of NOT malignant should be biopsied using ultrasound-guided (U/S-guided) fine-needle aspiration (FNA) biopsy.- - Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic
leukemia [CLL]) or other active disease capable of causing lymphadenopathy
(sarcoidosis or untreated mycobacterial infection)
- Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte
or immunomodulatory therapy.
- Currently participating in another investigational therapeutic trialTrial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
PRIMARY OBJECTIVES:
- I. To determine if patient-reported neck and shoulder function and related quality of life
(QOL) at 6 months after surgery using the Neck Dissection Impairment Index (NDII) is superior
with sentinel lymph node (SLN) biopsy compared to elective neck dissection (END) for
treatment of early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0).
(Phase II)- II. To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to
END for treatment of early-stage OCSCC (cT1-2N0).
(Phase III)- III. To determine if
patient-reported neck and shoulder function and related QOL at 6 months after surgery using
NDII is superior with SLN biopsy compared to END for treatment of early-stage OCSCC
(cT1-2N0).
(Phase III) SECONDARY OBJECTIVES:- IV. To measure longitudinal patient-reported neck and shoulder function and related QOL
between surgical arms, using the following instruments:
IVa.
Neck Dissection Impairment Index (NDII). IVb. Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH). IVc. Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N).- IX. To determine if patient-reported neck and
shoulder function and related QOL at 6 months after surgery using the NDII is superior with
the SLN biopsy compared to the END in low-risk patients.
EXPLORATORY OBJECTIVES:- III. To assess the DFS
between arms in low-risk patients.
OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive an imaging agent via injection and undergo planar imaging and single photo emission computed tomography/computed tomography (SPECT/CT) over 1-2 hours. Patients then undergo SLN biopsy. GROUP II: Patients undergo standard END. After completion of study treatment, patients are followed up 3 weeks after surgery, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then yearly thereafter.Arms
Experimental: Sentinel Lymph Node (SLN) Biopsy
Patients receive an imaging agent via injection and undergo planar imaging and SPECT/CT over 1-2 hours. Patients then undergo SLN biopsy.
Active Comparator: Elective Neck Dissection (END)
Patients undergo standard END.
Interventions
Procedure: - Computed Tomography (CT)
Undergo SPECT/CT scan
Drug: - Imaging Agent
Receive imaging agent via injection
Procedure: - Neck Dissection
Undergo standard elective neck dissection
Procedure: - Planar Imaging
Undergo planar imaging
Procedure: - Sentinel Lymph Node Biopsy
Undergo SLN biopsy
Procedure: - Single Photon Emission Computed Tomography
Undergo SPECT/CT scan
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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University of Arizona Cancer Center-North Campus
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650-498-7061
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203-785-5702
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203-785-5702
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UM Sylvester Comprehensive Cancer Center at Coral Gables
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305-243-2647
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305-243-2647
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Emory University Hospital Midtown
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888-946-7447
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404-778-1868
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312-695-1301
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Chicago, Illinois, 60612
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312-942-5498
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800-237-1225
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913-588-3671
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University of Kansas Hospital-Westwood Cancer Center
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913-588-3671
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University of Kentucky/Markey Cancer Center
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Louisville, Kentucky, 40202
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Shreveport, Louisiana, 71103
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318-813-1404
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Boston Medical Center
Boston, Massachusetts, 02118
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800-865-1125
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Wayne State University/Karmanos Cancer Institute
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313-576-9790
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Henry Ford Hospital
Detroit, Michigan, 48202
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313-916-3721
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Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
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313-576-9790
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Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska, 68114
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402-334-4773
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Nebraska Methodist Hospital
Omaha, Nebraska, 68114
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402-354-5144
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Oncology Associates PC
Omaha, Nebraska, 68114
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402-354-5860
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Basking Ridge, New Jersey, 07920
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212-639-7592
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Saint Barnabas Medical Center
Livingston, New Jersey, 07039
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973-322-2934
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
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212-639-7592
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
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212-639-7592
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
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732-235-7356
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Buffalo, New York, 14263
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800-767-9355
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Memorial Sloan Kettering Commack
Commack, New York, 11725
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212-639-7592
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604
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212-639-7592
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Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
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NYU Winthrop Hospital
Mineola, New York, 11501
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212-263-4432
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Long Island Jewish Medical Center
New Hyde Park, New York, 11040
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Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
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Lenox Hill Hospital
New York, New York, 10021
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Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065
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212-639-7592
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Uniondale, New York, 11553
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Fargo, North Dakota, 58122
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866-223-8100
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
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Oklahoma City, Oklahoma, 73104
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405-271-8777
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Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
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503-215-2614
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Providence Newberg Medical Center
Newberg, Oregon, 97132
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Providence Portland Medical Center
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Geisinger Medical Center
Danville, Pennsylvania, 17822
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570-271-5251
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Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
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215-600-9151
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Fox Chase Cancer Center
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Pittsburgh, Pennsylvania, 15232
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Pittsburgh, Pennsylvania, 15232
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Memphis, Tennessee, 38163
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901-683-0055
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Nashville, Tennessee, 37232
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Conroe, Texas, 77384
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866-632-6789
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713-798-1354
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877-632-6789
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Houston, Texas, 77030
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Houston, Texas, 77079
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877-632-6789
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MD Anderson League City
League City, Texas, 77573
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802-656-4101
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University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
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416-946-4501
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