Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer

February 5, 2024 updated by: NRG Oncology

Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

I. To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms.

II. To measure and compare overall survival (OS) between surgical arms. III. To measure and compare the toxicity of the two surgical arms.

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). V. To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms.

VI. To estimate the negative predictive rate of fludeoxyglucose F-18 (FDG)-positron emission tomography/computed tomography (PET/CT) for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm.

VII. To assess nodal metastases rates between arms. VIII. To assess the pathologic false omission rate (FOR) in the SLN biopsy arm. 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:

I. To compare changes in patient-reported outcomes (European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between surgical arms.

II. To collect biospecimens for future translational science studies. 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.

Study Type

Interventional

Enrollment (Estimated)

618

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network-Princess Margaret Hospital
        • Principal Investigator:
          • John R. de Almeida
        • Contact:
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner University Medical Center - Tucson
        • Principal Investigator:
          • Steven J. Wang
        • Contact:
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center-North Campus
        • Principal Investigator:
          • Steven J. Wang
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Principal Investigator:
          • Emre A. Vural
        • Contact:
          • Site Public Contact
          • Phone Number: 501-686-8274
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Principal Investigator:
          • Ellie G. Maghami
        • Contact:
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • Theresa Guo
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Institute Palo Alto
        • Principal Investigator:
          • Fred Baik
        • Contact:
      • Sacramento, California, United States, 95817
        • Active, not recruiting
        • University of California Davis Comprehensive Cancer Center
      • San Jose, California, United States, 95124
        • Recruiting
        • Stanford Cancer Center South Bay
        • Principal Investigator:
          • Fred Baik
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Principal Investigator:
          • Saral Mehra
        • Contact:
      • Trumbull, Connecticut, United States, 06611
        • Recruiting
        • Smilow Cancer Hospital Care Center-Trumbull
        • Principal Investigator:
          • Saral Mehra
        • Contact:
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Principal Investigator:
          • Francisco J. Civantos
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Principal Investigator:
          • Francisco J. Civantos
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Principal Investigator:
          • Francisco J. Civantos
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Principal Investigator:
          • Jennifer Gross
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Principal Investigator:
          • Jennifer Gross
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • Mihir K. Bhayani
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Sandeep Samant
        • Contact:
      • Springfield, Illinois, United States, 62781
        • Suspended
        • Memorial Medical Center
      • Springfield, Illinois, United States, 62702
        • Suspended
        • Southern Illinois University School of Medicine
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Principal Investigator:
          • Nitin A. Pagedar
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Principal Investigator:
          • Andres M. Bur
        • Contact:
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Principal Investigator:
          • Andres M. Bur
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Active, not recruiting
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, United States, 40202
        • Suspended
        • The James Graham Brown Cancer Center at University of Louisville
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • LSU Health Sciences Center at Shreveport
        • Principal Investigator:
          • John Pang
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Suspended
        • Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Principal Investigator:
          • Steven B. Chinn
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University/Karmanos Cancer Institute
        • Principal Investigator:
          • John D. Cramer
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Eleanor M. Walker
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Weisberg Cancer Treatment Center
        • Principal Investigator:
          • John D. Cramer
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
        • Principal Investigator:
          • Aru Panwar
        • Contact:
          • Site Public Contact
          • Phone Number: 402-334-4773
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital
        • Principal Investigator:
          • Aru Panwar
        • Contact:
          • Site Public Contact
          • Phone Number: 402-354-5144
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Oncology Associates PC
        • Principal Investigator:
          • Aru Panwar
        • Contact:
          • Site Public Contact
          • Phone Number: 402-354-5860
          • Email: info@oa-oc.com
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Principal Investigator:
          • Jennifer R. Cracchiolo
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • Livingston, New Jersey, United States, 07039
        • Recruiting
        • Saint Barnabas Medical Center
        • Principal Investigator:
          • Dylan F. Roden
        • Contact:
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Principal Investigator:
          • Jennifer R. Cracchiolo
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Principal Investigator:
          • Jennifer R. Cracchiolo
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Principal Investigator:
          • Dylan F. Roden
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Principal Investigator:
          • Ryan P. McSpadden
        • Contact:
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Principal Investigator:
          • Jennifer R. Cracchiolo
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Principal Investigator:
          • Jennifer R. Cracchiolo
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • Lake Success, New York, United States, 11042
        • Active, not recruiting
        • Northwell Health/Center for Advanced Medicine
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Winthrop Hospital
        • Principal Investigator:
          • Umamaheswar Duvvuri
        • Contact:
      • New Hyde Park, New York, United States, 11040
        • Active, not recruiting
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Jennifer R. Cracchiolo
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
        • Principal Investigator:
          • Umamaheswar Duvvuri
        • Contact:
      • New York, New York, United States, 10021
        • Active, not recruiting
        • Lenox Hill Hospital
      • New York, New York, United States, 10065
        • Active, not recruiting
        • Manhattan Eye Ear and Throat Hospital
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Principal Investigator:
          • Jennifer R. Cracchiolo
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Suspended
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58122
        • Suspended
        • Sanford Broadway Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Principal Investigator:
          • Jamie A. Ku
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Amit Agrawal
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Principal Investigator:
          • Rusha J. Patel
        • Contact:
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Newberg, Oregon, United States, 97132
        • Suspended
        • Providence Newberg Medical Center
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Contact:
        • Principal Investigator:
          • Nitya Alluri
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Principal Investigator:
          • Nicholas Purdy
        • Contact:
      • Hershey, Pennsylvania, United States, 17033-0850
        • Suspended
        • Penn State Milton S Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Principal Investigator:
          • David M. Cognetti
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19111
        • Active, not recruiting
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Principal Investigator:
          • Mark Kubik
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC-Shadyside Hospital
        • Principal Investigator:
          • Mark Kubik
        • Contact:
          • Site Public Contact
          • Phone Number: 412-621-2334
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
        • Principal Investigator:
          • William C. Spanos
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Recruiting
        • University of Tennessee Health Science Center
        • Contact:
        • Principal Investigator:
          • John P. Gleysteen
      • Memphis, Tennessee, United States, 38104
        • Recruiting
        • Methodist Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 901-516-2579
        • Principal Investigator:
          • John P. Gleysteen
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Principal Investigator:
          • Michael C. Topf
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
    • Texas
      • Conroe, Texas, United States, 77384
        • Recruiting
        • MD Anderson in The Woodlands
        • Principal Investigator:
          • Ann M. Gillenwater
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Principal Investigator:
          • Ann M. Gillenwater
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Principal Investigator:
          • Vlad C. Sandulache
        • Contact:
          • Site Public Contact
          • Phone Number: 713-798-1354
          • Email: burton@bcm.edu
      • Houston, Texas, United States, 77079
        • Recruiting
        • MD Anderson West Houston
        • Principal Investigator:
          • Ann M. Gillenwater
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Michael E DeBakey VA Medical Center
        • Principal Investigator:
          • Vlad C. Sandulache
        • Contact:
          • Site Public Contact
          • Phone Number: 800-553-2278
      • League City, Texas, United States, 77573
        • Recruiting
        • MD Anderson League City
        • Principal Investigator:
          • Ann M. Gillenwater
        • Contact:
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • MD Anderson in Sugar Land
        • Principal Investigator:
          • Ann M. Gillenwater
        • Contact:
    • Vermont
      • Berlin, Vermont, United States, 05602
        • Recruiting
        • Central Vermont Medical Center/National Life Cancer Treatment
        • Principal Investigator:
          • Mirabelle Sajisevi
        • Contact:
          • Site Public Contact
          • Phone Number: 802-225-5400
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Principal Investigator:
          • Mirabelle Sajisevi
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-4101
          • Email: rpo@uvm.edu
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont and State Agricultural College
        • Principal Investigator:
          • Mirabelle Sajisevi
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-8990
          • Email: rpo@uvm.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PRIOR TO STEP 1 REGISTRATION INCLUSION:
  • Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oral cavity, including the oral (mobile) tongue, floor of mouth (FOM), mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone; RMT), or hard palate prior to registration

  • Appropriate stage for study entry (T1-2N0M0; American Joint Committee on Cancer [AJCC] 8th edition [ed.]) based on the following diagnostic workup:

    • History/physical examination within 42 days prior to registration

    • Imaging of head and neck within 42 days prior to registration

      • PET/CT scan or contrast neck CT scan, or gadolinium-enhanced neck magnetic resonance imaging (MRI) or lateral and central neck ultrasound; diagnostic quality CT is preferred and highly recommended for the PET/CT when possible.
      • 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)

    • Surgical resection of the primary tumor will occur through a transoral approach with anticipation of resection free margins
  • Zubrod performance status 0-2 within 42 days prior to registration
  • For women of child-bearing potential, negative serum or urine pregnancy test within 42 days prior to registration
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • Only patients who are able to read and understand English are eligible to participate as the mandatory patient reported NDII tool is only available in this language
  • 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.

    • PET/CT node negative patients, determined by central read, will proceed to randomization.

    • PET/CT node positive patients will go off study, but will be entered in a registry and data will be collected to record the pathological outcome of neck nodes for diagnostic imaging assessment and future clinical trial development

      • NOTE: All FDG PET/CT scans must be performed on an American College of Radiology (ACR) accredited scanner (or similar accrediting organization)
  • The patient must complete NDII prior to step 2 registration

Exclusion Criteria:

  • PRIOR TO STEP 1 REGISTRATION EXCLUSION:
  • Definitive clinical or radiologic evidence of regional (cervical) and/or distant metastatic disease
  • Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer, including effectively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix) unless disease free for ≥ 2 years
  • Diagnosis of head and neck squamous cell carcinoma (SCC) in the oropharynx, nasopharynx, hypopharynx, and larynx
  • Unable or unwilling to complete NDII (baseline only)
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection
  • Pregnancy and breast-feeding mothers
  • Incomplete resection of oral cavity lesion with a positive margin; however, an excisional biopsy is permitted
  • 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 trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Sentinel Lymph Node Biopsy
Undergo SLN biopsy
Other Names:
  • Sentinel Node Biopsy
  • Sentinel node biopsy alone
  • SLNB
  • SNB
Procedure: Planar Imaging
Undergo planar imaging
Procedure: Computed Tomography (CT)
Undergo SPECT/CT scan
Other Names:
  • CT
  • CAT
  • Computerized Tomography
  • tomography
  • computerized axial tomography
  • CAT scan
  • CT scan
  • Computed Tomography
Drug: Imaging Agent
Receive imaging agent via injection
Other Names:
  • Image Enhancement Agent
Procedure: Single Photon Emission Computed Tomography
Undergo SPECT/CT scan
Other Names:
  • Medical Imaging, Single Photon Emission Computed Tomography
  • Single Photon Emission Tomography
  • single-photon emission computed tomography
  • SPECT
  • SPECT imaging
  • SPECT SCAN
  • SPET
  • tomography, emission computed, single photon
  • Tomography, Emission-Computed, Single-Photon
Active Comparator: Elective Neck Dissection (END)
Patients undergo standard END.
Procedure: Computed Tomography (CT)
Undergo SPECT/CT scan
Other Names:
  • CT
  • CAT
  • Computerized Tomography
  • tomography
  • computerized axial tomography
  • CAT scan
  • CT scan
  • Computed Tomography
Procedure: Neck Dissection
Undergo standard elective neck dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported neck and shoulder function (Phase II/III)
Time Frame: From Baseline (Before surgery) to 6 months post-surgery
Will be evaluated and compared using the Neck Dissection Impairment Index (NDII), a 10-item tool between the two treatment arms. It is assumed that a 7.5-point (change from Baseline to 6 months) between arm difference is clinically meaningful. The hypothesis of no between-arm difference in 6-month NDII scores will be tested using the ANCOVA model at one-sided significance level of 0.10. Point estimates and 95% confidence intervals (CIs) for the mean NDII scores at 6 months for each treatment arm and for the between-arm difference at 6-months based on the proposed model will be provided.
From Baseline (Before surgery) to 6 months post-surgery
Disease-Free Survival
Time Frame: From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years
An event for disease-free survival is local recurrence, regional recurrence, distant metastasis, or death due to any cause. Disease-free survival time is randomization date to the date of event or last known follow-up (censoring). Rates will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.
From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From randomization to death due to any cause, assessed up to 11 years
An event for overall survival is death due to any cause. Overall survival time is randomization date to date of event or last known follow-up (censoring). Rates will be estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.
From randomization to death due to any cause, assessed up to 11 years
Loco-regional Failure
Time Frame: From the time of randomization to the date of failure, date of precluding event, or last known follow-up date, assessed up to 11 years
An event for local-regional failure is local or regional recurrence. Local-regional failure time is randomization date to date of event, precluding event, or last known follow-up (censoring). Rates will be estimated using the cumulative incidence method and between arm differences compared using cause-specific log-rank test.
From the time of randomization to the date of failure, date of precluding event, or last known follow-up date, assessed up to 11 years
Distant metastasis
Time Frame: From the time of randomization to the date of distant metastasis, date of precluding event, or last known follow-up date, assessed up to 11 years
An event is the occurrence of distant metastasis. Distant metastasis time is randomization to date of event, precluding event, or last known follow-up (censoring). Rates will be estimated using the cumulative incidence method and between-arm differences compared using cause-specific log-rank test.
From the time of randomization to the date of distant metastasis, date of precluding event, or last known follow-up date, assessed up to 11 years
Patient-reported shoulder-related QOL, function impairment and disability
Time Frame: Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint.
Patient reported using Abbreviated Disabilities of the Arm, Shoulder, and Hand (QuickDASH) with scores of 0-100. A higher score indicates greater disability.
Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint.
General quality of life
Time Frame: Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint.
Will be measured using the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) to measure Functional Assessment of Cancer Therapy-Head and Neck-Trial Outcome Index (FACT-TOI) scores on a scale from 0-96. A higher score indicates better quality of life.
Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint.
Nodal metastasis detection rate
Time Frame: During surgery. Analysis occurs at the same time as the primary endpoint.
Defined as the proportion of patients with pathologic positive nodes using the pathology results.
During surgery. Analysis occurs at the same time as the primary endpoint.
Pathologic false omission rate
Time Frame: During surgery. Analysis occurs at the same time as the primary endpoint.
Measured within the sentinel lymph node biopsy (SLN) arm only. Defined as the proportion of patients with false negative results among negative SLN patients.
During surgery. Analysis occurs at the same time as the primary endpoint.
Post-surgery patient-reported outcome
Time Frame: At 6 months post-surgery. Analysis occurs at the same time as the primary endpoint.
Measured by NDII in low-risk oral cavity squamous cell carcinoma patients using ANCOVA comparison model.
At 6 months post-surgery. Analysis occurs at the same time as the primary endpoint.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NRG Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Stephen Y Lai, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2020

Primary Completion (Estimated)

May 18, 2031

Study Completion (Estimated)

May 18, 2036

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRG-HN006 (Other Identifier: CTEP)
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NCI-2020-01542 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oral Cavity Squamous Cell Carcinoma

Clinical Trials on Sentinel Lymph Node Biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe