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.
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…
Contacts
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