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Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
NCT04333537 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Chest Radiography
- OTHER Fludeoxyglucose F-18
- DRUG Imaging Agent
- PROCEDURE Neck Dissection
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center — Duarte
- UC San Diego Moores Cancer Center — La Jolla
- Stanford Cancer Institute Palo Alto — Palo Alto
- University of California Davis Comprehensive Cancer Center — Sacramento
- UC San Diego Medical Center - Hillcrest — San Diego
- UCSF Medical Center-Mission Bay — San Francisco
- Stanford Cancer Center South Bay — San Jose
Arizona
- Banner MD Anderson Cancer Center — Gilbert
- Mayo Clinic Hospital in Arizona — Phoenix
- Banner University Medical Center - Tucson — Tucson
- University of Arizona Cancer Center-North Campus — Tucson
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
Connecticut
- Yale University — New Haven
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull
Georgia
- Emory University Hospital Midtown — Atlanta
- Emory University Hospital/Winship Cancer Institute — Atlanta
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
Arkansas
- University of Arkansas for Medical Sciences — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 686 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2031-04-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04333537
The ClinicalTrials.gov registry entry for NCT04333537 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 686 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NRG Oncology, which has 162 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Oral Cavity Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Computed Tomography is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04333537 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04333537 about?
NCT04333537 is a clinical study titled "Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With 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 ...
What is the current status of trial NCT04333537?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 686 participants. The study started on 2020-09-23. Estimated completion is 2031-04-27.
What conditions does trial NCT04333537 study?
This clinical trial studies the following conditions: Oral Cavity Squamous Cell Carcinoma, Stage II Lip and Oral Cavity Cancer AJCC v8, Stage I Lip and Oral Cavity Cancer AJCC v8, Buccal Mucosa Squamous Cell Carcinoma, Floor of Mouth Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04333537?
The interventions under investigation include: Computed Tomography (PROCEDURE), Chest Radiography (PROCEDURE), Fludeoxyglucose F-18 (OTHER), Imaging Agent (DRUG), Neck Dissection (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04333537?
This trial is sponsored by NRG Oncology, which has 162 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04333537 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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