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Sentinel Lymph Node Biopsy vs Neck Dissection for Oral Cancer

Phase 2 & 3
Recruiting
Led By Stephen Y Lai
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Surgical resection of the primary tumor through a transoral approach
Pathologically proven diagnosis of squamous cell carcinoma of specific oral cavity sites
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to death due to any cause, assessed up to 11 years
Awards & highlights

Study Summary

This trial compares sentinel lymph node biopsy surgery to standard neck dissection for early-stage oral cavity cancer.

Who is the study for?
This trial is for adults with early-stage oral cavity cancer, including cancers of the tongue, floor of mouth, and other areas within the oral cavity. They must be candidates for surgery through a transoral approach and have no evidence of distant metastatic disease. Pregnant or breastfeeding women are excluded, as well as those with severe co-morbidities or who have had certain prior treatments.Check my eligibility
What is being tested?
The study compares sentinel lymph node biopsy (SLNB) to standard neck dissection in treating early-stage oral cavity cancer. SLNB uses an imaging agent to identify key lymph nodes for removal, potentially offering a less extensive surgery than traditional neck dissection which removes many lymph nodes.See study design
What are the potential side effects?
Potential side effects may include pain and swelling at the surgical site, risk of infection, nerve damage leading to numbness or weakness, difficulty swallowing if nerves affecting muscles are impacted, and general risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My primary tumor was removed through my mouth.
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I have been diagnosed with squamous cell carcinoma in my mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to death due to any cause, assessed up to 11 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death due to any cause, assessed up to 11 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-Free Survival
Patient-reported neck and shoulder function (Phase II/III)
Secondary outcome measures
Distant metastasis
General quality of life
Loco-regional Failure
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sentinel Lymph Node (SLN) BiopsyExperimental Treatment5 Interventions
Patients receive an imaging agent via injection and undergo planar imaging and SPECT/CT over 1-2 hours. Patients then undergo SLN biopsy.
Group II: Elective Neck Dissection (END)Active Control2 Interventions
Patients undergo standard END.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography (CT)
2012
N/A
~100
Sentinel Lymph Node Biopsy
2004
Completed Phase 3
~330
Imaging Agent
2018
Completed Phase 1
~20
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,723 Total Patients Enrolled
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,234 Total Patients Enrolled
Stephen Y LaiPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
467 Total Patients Enrolled

Media Library

Neck Dissection Clinical Trial Eligibility Overview. Trial Name: NCT04333537 — Phase 2 & 3
Squamous Cell Carcinoma Research Study Groups: Sentinel Lymph Node (SLN) Biopsy, Elective Neck Dissection (END)
Squamous Cell Carcinoma Clinical Trial 2023: Neck Dissection Highlights & Side Effects. Trial Name: NCT04333537 — Phase 2 & 3
Neck Dissection 2023 Treatment Timeline for Medical Study. Trial Name: NCT04333537 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being enrolled in this clinical trial?

"That is correct. The clinicaltrials.gov website says that the trial is recruiting patients. This particular study was posted on 7/8/2020 and was edited as recently as 8/12/2022. There are 64 locations enrolling a total of 618 participants."

Answered by AI

Are new participants still being sought for this experiment?

"This is an active clinical trial that is currently recruiting participants, as shown on clinicaltrials.gov. The study was posted on 7/8/2020 and was most recently edited on 8/12/2022."

Answered by AI

Could you tell me how many different hospitals are testing this new treatment?

"There are currently 64 active sites for this trial, with locations such as Harrison's Memorial Sloan Kettering Westchester, Stanford Cancer Institute Palo Alto in Palo Alto, and MD Anderson in Sugar Land."

Answered by AI

What are the goals of this research?

"The main aim of this clinical trial is to assess Disease-Free Survival over a 6-month period, with secondary outcomes including Loco-regional Failure and Overall Survival. General quality of life will also be measured using the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) scale."

Answered by AI
~404 spots leftby May 2031