Comparing Sentinel Lymph Node Biopsy for Oral Cavity Cancer

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
Who this trial is looking for

This trial is looking for patients with early-stage oral cavity cancer to compare two surgical methods for treating their condition. Participants will undergo imaging tests and a specific type of biopsy instead of a more extensive surgery.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with oral cavity squamous cell carcinoma.
  • I am between 18 and 99 years old.
  • I have an appropriate stage for study entry as defined by my doctor.
  • I am able to provide informed consent.
  • I can read and understand English or French.
  • My physical exams and imaging tests were done within the last 42 days.

You may not be able to join if

  • I have evidence of cancer spreading to nearby or distant areas.
  • I have had another invasive cancer in the past two years, other than skin cancer.
  • I have been diagnosed with squamous cell carcinoma in the throat or voice box.
  • I am pregnant or breastfeeding.
  • I cannot complete the required questionnaire.
  • I have had previous surgery on the lateral neck.
  • I have an active blood disorder or another illness causing swollen lymph nodes.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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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