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

Primary Purpose

Buccal Mucosa Squamous Cell Carcinoma, Floor of Mouth Squamous Cell Carcinoma, Gingival Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Computed Tomography (CT)
Imaging Agent
Neck Dissection
Planar Imaging
Sentinel Lymph Node Biopsy
Single Photon Emission Computed Tomography
Sponsored by
NRG Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Buccal Mucosa Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner University Medical Center - TucsonRecruiting
  • University of Arizona Cancer Center-North CampusRecruiting
  • University of Arkansas for Medical SciencesRecruiting
  • City of Hope Comprehensive Cancer CenterRecruiting
  • UC San Diego Moores Cancer CenterRecruiting
  • Stanford Cancer Institute Palo AltoRecruiting
  • University of California Davis Comprehensive Cancer Center
  • Yale UniversityRecruiting
  • Smilow Cancer Hospital Care Center-TrumbullRecruiting
  • UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
  • UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
  • Emory University Hospital MidtownRecruiting
  • Emory University Hospital/Winship Cancer InstituteRecruiting
  • Northwestern UniversityRecruiting
  • Rush University Medical CenterRecruiting
  • Southern Illinois University School of Medicine
  • Memorial Medical Center
  • University of Iowa/Holden Comprehensive Cancer CenterRecruiting
  • University of Kansas Cancer CenterRecruiting
  • University of Kansas Hospital-Westwood Cancer CenterRecruiting
  • University of Kentucky/Markey Cancer Center
  • The James Graham Brown Cancer Center at University of LouisvilleRecruiting
  • LSU Health Sciences Center at ShreveportRecruiting
  • Boston Medical Center
  • University of Michigan Comprehensive Cancer CenterRecruiting
  • Wayne State University/Karmanos Cancer InstituteRecruiting
  • Henry Ford HospitalRecruiting
  • Weisberg Cancer Treatment CenterRecruiting
  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECCRecruiting
  • Nebraska Methodist HospitalRecruiting
  • Oncology Associates PCRecruiting
  • Memorial Sloan Kettering Basking RidgeRecruiting
  • Saint Barnabas Medical CenterRecruiting
  • Memorial Sloan Kettering MonmouthRecruiting
  • Memorial Sloan Kettering BergenRecruiting
  • Rutgers Cancer Institute of New JerseyRecruiting
  • Roswell Park Cancer InstituteRecruiting
  • Memorial Sloan Kettering CommackRecruiting
  • Memorial Sloan Kettering WestchesterRecruiting
  • Northwell Health/Center for Advanced Medicine
  • Long Island Jewish Medical Center
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • Lenox Hill HospitalRecruiting
  • Manhattan Eye Ear and Throat HospitalRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering NassauRecruiting
  • Sanford Broadway Medical CenterRecruiting
  • Sanford Roger Maris Cancer CenterRecruiting
  • Cleveland Clinic FoundationRecruiting
  • Ohio State University Comprehensive Cancer CenterRecruiting
  • University of Oklahoma Health Sciences CenterRecruiting
  • Clackamas Radiation Oncology CenterRecruiting
  • Providence Newberg Medical Center
  • Providence Portland Medical CenterRecruiting
  • Providence Saint Vincent Medical CenterRecruiting
  • Geisinger Medical CenterRecruiting
  • Penn State Milton S Hershey Medical CenterRecruiting
  • Thomas Jefferson University HospitalRecruiting
  • Fox Chase Cancer Center
  • University of Pittsburgh Cancer Institute (UPCI)Recruiting
  • UPMC-Shadyside HospitalRecruiting
  • Sanford Cancer Center Oncology ClinicRecruiting
  • Avera Cancer InstituteRecruiting
  • Sanford USD Medical Center - Sioux FallsRecruiting
  • Methodist HospitalRecruiting
  • University of Tennessee Health Science CenterRecruiting
  • Vanderbilt University/Ingram Cancer CenterRecruiting
  • MD Anderson in The WoodlandsRecruiting
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
  • M D Anderson Cancer CenterRecruiting
  • Michael E DeBakey VA Medical CenterRecruiting
  • MD Anderson West HoustonRecruiting
  • MD Anderson League CityRecruiting
  • MD Anderson in Sugar LandRecruiting
  • Central Vermont Medical Center/National Life Cancer TreatmentRecruiting
  • University of Vermont Medical CenterRecruiting
  • University of Vermont and State Agricultural CollegeRecruiting
  • University Health Network-Princess Margaret HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sentinel Lymph Node (SLN) Biopsy

Elective Neck Dissection (END)

Arm Description

Patients receive an imaging agent via injection and undergo planar imaging and SPECT/CT over 1-2 hours. Patients then undergo SLN biopsy.

Patients undergo standard END.

Outcomes

Primary Outcome Measures

Patient-reported neck and shoulder function (Phase II/III)
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.
Disease-Free Survival
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.

Secondary Outcome Measures

Overall Survival
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.
Loco-regional Failure
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.
Distant metastasis
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.
Patient-reported shoulder-related QOL, function impairment and disability
Patient reported using Abbreviated Disabilities of the Arm, Shoulder, and Hand (QuickDASH) with scores of 0-100. A higher score indicates greater disability.
General quality of life
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.
Nodal metastasis detection rate
Defined as the proportion of patients with pathologic positive nodes using the pathology results.
Pathologic false omission rate
Measured within the sentinel lymph node biopsy (SLN) arm only. Defined as the proportion of patients with false negative results among negative SLN patients.
Post-surgery patient-reported outcome
Measured by NDII in low-risk oral cavity squamous cell carcinoma patients using ANCOVA comparison model.

Full Information

First Posted
March 26, 2020
Last Updated
September 11, 2023
Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04333537
Brief Title
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
Official Title
Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2020 (Actual)
Primary Completion Date
May 18, 2031 (Anticipated)
Study Completion Date
May 18, 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Buccal Mucosa Squamous Cell Carcinoma, Floor of Mouth Squamous Cell Carcinoma, Gingival Squamous Cell Carcinoma, Hard Palate Squamous Cell Carcinoma, Lip Squamous Cell Carcinoma, Lower Alveolar Ridge Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Retromolar Trigone Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Tongue Squamous Cell Carcinoma, Upper Alveolar Ridge Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
618 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sentinel Lymph Node (SLN) Biopsy
Arm Type
Experimental
Arm Description
Patients receive an imaging agent via injection and undergo planar imaging and SPECT/CT over 1-2 hours. Patients then undergo SLN biopsy.
Arm Title
Elective Neck Dissection (END)
Arm Type
Active Comparator
Arm Description
Patients undergo standard END.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography (CT)
Other Intervention Name(s)
CAT, CAT scan, Computed Tomography, computerized axial tomography, Computerized Tomography, CT, CT scan, tomography
Intervention Description
Undergo SPECT/CT scan
Intervention Type
Drug
Intervention Name(s)
Imaging Agent
Other Intervention Name(s)
Image Enhancement Agent
Intervention Description
Receive imaging agent via injection
Intervention Type
Procedure
Intervention Name(s)
Neck Dissection
Intervention Description
Undergo standard elective neck dissection
Intervention Type
Procedure
Intervention Name(s)
Planar Imaging
Intervention Description
Undergo planar imaging
Intervention Type
Procedure
Intervention Name(s)
Sentinel Lymph Node Biopsy
Other Intervention Name(s)
Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Intervention Description
Undergo SLN biopsy
Intervention Type
Procedure
Intervention Name(s)
Single Photon Emission Computed Tomography
Other Intervention Name(s)
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
Intervention Description
Undergo SPECT/CT scan
Primary Outcome Measure Information:
Title
Patient-reported neck and shoulder function (Phase II/III)
Description
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.
Time Frame
From Baseline (Before surgery) to 6 months post-surgery
Title
Disease-Free Survival
Description
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.
Time Frame
From randomization to local/regional recurrence, distant metastasis, or death due to any cause, whichever comes first, assessed up to 11 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
From randomization to death due to any cause, assessed up to 11 years
Title
Loco-regional Failure
Description
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.
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
Title
Distant metastasis
Description
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.
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
Title
Patient-reported shoulder-related QOL, function impairment and disability
Description
Patient reported using Abbreviated Disabilities of the Arm, Shoulder, and Hand (QuickDASH) with scores of 0-100. A higher score indicates greater disability.
Time Frame
Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint.
Title
General quality of life
Description
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.
Time Frame
Baseline, 3 weeks, 3, 6, 12 months post-surgery. Analysis occurs at the same time as the primary endpoint.
Title
Nodal metastasis detection rate
Description
Defined as the proportion of patients with pathologic positive nodes using the pathology results.
Time Frame
During surgery. Analysis occurs at the same time as the primary endpoint.
Title
Pathologic false omission rate
Description
Measured within the sentinel lymph node biopsy (SLN) arm only. Defined as the proportion of patients with false negative results among negative SLN patients.
Time Frame
During surgery. Analysis occurs at the same time as the primary endpoint.
Title
Post-surgery patient-reported outcome
Description
Measured by NDII in low-risk oral cavity squamous cell carcinoma patients using ANCOVA comparison model.
Time Frame
At 6 months post-surgery. Analysis occurs at the same time as the primary endpoint.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Y Lai
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
UACC-IIT@uacc.arizona.edu
First Name & Middle Initial & Last Name & Degree
Steven J. Wang
Facility Name
University of Arizona Cancer Center-North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
UACC-IIT@uacc.arizona.edu
First Name & Middle Initial & Last Name & Degree
Steven J. Wang
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
501-686-8274
First Name & Middle Initial & Last Name & Degree
Emre A. Vural
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-826-4673
Email
becomingapatient@coh.org
First Name & Middle Initial & Last Name & Degree
Ellie G. Maghami
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
858-822-5354
Email
cancercto@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Theresa Guo
Facility Name
Stanford Cancer Institute Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
650-498-7061
Email
ccto-office@stanford.edu
First Name & Middle Initial & Last Name & Degree
Fred Baik
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Saral Mehra
Facility Name
Smilow Cancer Hospital Care Center-Trumbull
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
203-785-5702
Email
canceranswers@yale.edu
First Name & Middle Initial & Last Name & Degree
Saral Mehra
Facility Name
UM Sylvester Comprehensive Cancer Center at Coral Gables
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
305-243-2647
First Name & Middle Initial & Last Name & Degree
Francisco J. Civantos
Facility Name
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
305-243-2647
First Name & Middle Initial & Last Name & Degree
Francisco J. Civantos
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
305-243-2647
First Name & Middle Initial & Last Name & Degree
Francisco J. Civantos
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-946-7447
First Name & Middle Initial & Last Name & Degree
Jennifer Gross
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
404-778-1868
First Name & Middle Initial & Last Name & Degree
Jennifer Gross
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
312-695-1301
Email
cancer@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Sandeep Samant
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
312-942-5498
Email
clinical_trials@rush.edu
First Name & Middle Initial & Last Name & Degree
Mihir K. Bhayani
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Suspended
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Individual Site Status
Suspended
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-237-1225
First Name & Middle Initial & Last Name & Degree
Nitin A. Pagedar
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-588-3671
Email
KUCC_Navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Andres M. Bur
Facility Name
University of Kansas Hospital-Westwood Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
913-588-3671
Email
KUCC_Navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Andres M. Bur
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The James Graham Brown Cancer Center at University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
502-562-3429
First Name & Middle Initial & Last Name & Degree
Neal E. Dunlap
Facility Name
LSU Health Sciences Center at Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
318-813-1404
Email
LPost@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
John Pang
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Suspended
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-865-1125
First Name & Middle Initial & Last Name & Degree
Steven B. Chinn
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-576-9790
Email
ctoadmin@karmanos.org
First Name & Middle Initial & Last Name & Degree
John D. Cramer
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-916-3721
Email
CTOResearch@hfhs.org
First Name & Middle Initial & Last Name & Degree
Eleanor M. Walker
Facility Name
Weisberg Cancer Treatment Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-576-9790
Email
ctoadmin@karmanos.org
First Name & Middle Initial & Last Name & Degree
John D. Cramer
Facility Name
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
402-334-4773
First Name & Middle Initial & Last Name & Degree
Aru Panwar
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
402-354-5144
First Name & Middle Initial & Last Name & Degree
Aru Panwar
Facility Name
Oncology Associates PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
402-354-5860
Email
info@oa-oc.com
First Name & Middle Initial & Last Name & Degree
Aru Panwar
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Jennifer R. Cracchiolo
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
973-322-2934
Email
joanne.loeb@rwjbh.org
First Name & Middle Initial & Last Name & Degree
Dylan F. Roden
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Jennifer R. Cracchiolo
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Jennifer R. Cracchiolo
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
732-235-7356
First Name & Middle Initial & Last Name & Degree
Dylan F. Roden
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-767-9355
Email
askroswell@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Ryan P. McSpadden
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Jennifer R. Cracchiolo
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Jennifer R. Cracchiolo
Facility Name
Northwell Health/Center for Advanced Medicine
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Suspended
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Suspended
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Suspended
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
516-734-8896
First Name & Middle Initial & Last Name & Degree
Douglas K. Frank
Facility Name
Manhattan Eye Ear and Throat Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-434-4460
First Name & Middle Initial & Last Name & Degree
Douglas K. Frank
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Jennifer R. Cracchiolo
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Jennifer R. Cracchiolo
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
701-323-5760
Email
OncologyClinicalTrialsFargo@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
Sanford Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
701-234-6161
Email
OncologyClinicalTrialsFargo@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
866-223-8100
Email
TaussigResearch@ccf.org
First Name & Middle Initial & Last Name & Degree
Jamie A. Ku
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-293-5066
Email
Jamesline@osumc.edu
First Name & Middle Initial & Last Name & Degree
Amit Agrawal
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
405-271-8777
Email
ou-clinical-trials@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Rusha J. Patel
Facility Name
Clackamas Radiation Oncology Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
503-215-2614
Email
CanRsrchStudies@providence.org
First Name & Middle Initial & Last Name & Degree
Nitya Alluri
Facility Name
Providence Newberg Medical Center
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Individual Site Status
Suspended
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
503-215-2614
Email
CanRsrchStudies@providence.org
First Name & Middle Initial & Last Name & Degree
Nitya Alluri
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
503-215-2614
Email
CanRsrchStudies@providence.org
First Name & Middle Initial & Last Name & Degree
Nitya Alluri
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
570-271-5251
Email
HemonCCTrials@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Nicholas Purdy
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
717-531-3779
Email
CTO@hmc.psu.edu
First Name & Middle Initial & Last Name & Degree
Karen Y. Choi
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
215-600-9151
Email
ONCTrialNow@jefferson.edu
First Name & Middle Initial & Last Name & Degree
David M. Cognetti
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Pittsburgh Cancer Institute (UPCI)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-647-8073
First Name & Middle Initial & Last Name & Degree
Mark Kubik
Facility Name
UPMC-Shadyside Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-621-2334
First Name & Middle Initial & Last Name & Degree
Mark Kubik
Facility Name
Sanford Cancer Center Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
605-312-3320
Email
OncologyClinicTrialsSF@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
605-322-3095
Email
OncRegulatory@avera.org
First Name & Middle Initial & Last Name & Degree
William C. Spanos
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
605-312-3320
Email
OncologyClinicalTrialsSF@SanfordHealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
Methodist Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
901-516-2579
First Name & Middle Initial & Last Name & Degree
John P. Gleysteen
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
901-683-0055
Email
afletcher@westclinic.com
First Name & Middle Initial & Last Name & Degree
John P. Gleysteen
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-811-8480
First Name & Middle Initial & Last Name & Degree
Michael C. Topf
Facility Name
MD Anderson in The Woodlands
City
Conroe
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
866-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Ann M. Gillenwater
Facility Name
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
713-798-1354
Email
burton@bcm.edu
First Name & Middle Initial & Last Name & Degree
Vlad C. Sandulache
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Ann M. Gillenwater
Facility Name
Michael E DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-553-2278
First Name & Middle Initial & Last Name & Degree
Vlad C. Sandulache
Facility Name
MD Anderson West Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Ann M. Gillenwater
Facility Name
MD Anderson League City
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Ann M. Gillenwater
Facility Name
MD Anderson in Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-632-6789
Email
askmdanderson@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Ann M. Gillenwater
Facility Name
Central Vermont Medical Center/National Life Cancer Treatment
City
Berlin
State/Province
Vermont
ZIP/Postal Code
05602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
802-225-5400
First Name & Middle Initial & Last Name & Degree
Mirabelle Sajisevi
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
802-656-4101
Email
rpo@uvm.edu
First Name & Middle Initial & Last Name & Degree
Mirabelle Sajisevi
Facility Name
University of Vermont and State Agricultural College
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
802-656-8990
Email
rpo@uvm.edu
First Name & Middle Initial & Last Name & Degree
Mirabelle Sajisevi
Facility Name
University Health Network-Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
416-946-4501
Email
clinical.trials@uhn.on.ca
First Name & Middle Initial & Last Name & Degree
John R. de Almeida

12. IPD Sharing Statement

Learn more about this trial

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

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