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NCT04333537 · ClinicalTrials.gov registry record · Phase 2
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
A Phase 2 study of Oral Cavity Squamous Cell Carcinoma and Stage II Lip and Oral Cavity Cancer AJCC v8, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 686
- Enrollment target
- 20
- Study locations
NCT04333537: Recruiting Phase 2 study of Oral Cavity Squamous Cell Carcinoma and Stage II Lip and Oral Cavity Cancer AJCC v8, sponsored by NRG Oncology.
NCT04333537 is a Phase 2 study of Oral Cavity Squamous Cell Carcinoma and Stage II Lip and Oral Cavity Cancer AJCC v8 that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 686 participants, above the 53-participant average among 8 other Oral Cavity Squamous Cell Carcinoma trials with a reported enrollment target (1194% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04333537, a Phase 2 study of Oral Cavity Squamous Cell Carcinoma and Stage II Lip and Oral Cavity Cancer AJCC v8, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 686 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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 between arm difference in the 6-month post-surgery NDII scores is clinically meaningful.
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 |
What NCT04333537 shows while recruiting
NCT04333537 is an interventional study that assigns participants to a tested intervention. The registered 686 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 8 other Oral Cavity Squamous Cell Carcinoma trials with a reported enrollment target (1194% higher).
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.
NCT04333537 names 20 study sites across 7 states, led by California, Arizona, Florida.
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.
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).
Who is sponsoring clinical trial NCT04333537?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Oral Cavity Squamous Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04333537's enrollment target sits among peer trials
686 1st of 8 higher than 8 of 8 other Oral Cavity Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oral Cavity Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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