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

Recruiting Phase 2 Phase 3 Interventional 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
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
686 (estimated)
Sponsor
NRG Oncology · Other
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About This Trial
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 ha…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * PRIOR TO STEP 1 REGISTRATION INCLUSION: * Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (SCC) of the oral cavity, including the oral (mobile) tongue, floor of mouth (FOM), mucosal lip, buccal mucosa, lower alveolar ridge, upper al…
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