Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 2/Phase 3
Funding Agency/Sponsor
National Cooperative Group
Disease
Head and Neck Cancer
Enrollment Eligibility
Inclusion Criteria:
- PRIOR TO STEP 1 REGISTRATION INCLUSION:
- Pathologically (histologically or cytologically) proven diagnosis of squamous cell
carcinoma of the oral cavity, including the oral (mobile) tongue, floor of mouth
(FOM), mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge,
retromolar gingiva (retromolar trigone; RMT), or hard palate prior to registration
- Appropriate stage for study entry (T1-2N0M0; American Joint Committee on Cancer [AJCC]
8th edition [ed.]) based on the following diagnostic workup:
- History/physical examination within 42 days prior to registration
- Imaging of head and neck within 42 days prior to registration
- PET/CT scan or contrast neck CT scan, or gadolinium-enhanced neck magnetic
resonance imaging (MRI) or lateral and central neck ultrasound; diagnostic
quality CT is preferred and highly recommended for the PET/CT when possible.
- Imaging of chest within 42 days prior to registration; chest x-ray, CT chest
scan (with or without contrast) or PET/CT (with or without contrast)
- Surgical assessment within 42 days prior to registration. Patient must be a candidate
for surgical intervention with sentinel lymph node (SLN) biopsy and potential
completion neck dissection (CND) or elective neck dissection (END)
- Surgical resection of the primary tumor will occur through a transoral approach
with anticipation of resection free margins
- Zubrod performance status 0-2 within 42 days prior to registration
- For women of child-bearing potential, negative serum or urine pregnancy test within 42
days prior to registration
- The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry
- Only patients who are able to read and understand English are eligible to participate
as the mandatory patient reported NDII tool is only available in this language
- PRIOR TO STEP 2 RANDOMIZATION:
- FDG PET/CT required prior to step 2. Note: FDG PET/CT done prior to step 1 can be
submitted for central review.
- PET/CT node negative patients, determined by central read, will proceed to
randomization.
- PET/CT node positive patients will go off study, but will be entered in a
registry and data will be collected to record the pathological outcome of neck
nodes for diagnostic imaging assessment and future clinical trial development
- NOTE: All FDG PET/CT scans must be performed on an American College of
Radiology (ACR) accredited scanner (or similar accrediting organization)
- The patient must complete NDII prior to step 2 registration
Exclusion Criteria:
- PRIOR TO STEP 1 REGISTRATION EXCLUSION:
- Definitive clinical or radiologic evidence of regional (cervical) and/or distant
metastatic disease
- Prior non-head and neck invasive malignancy (except non-melanomatous skin cancer,
including effectively treated basal cell or squamous cell skin cancer, or carcinoma in
situ of the breast or cervix) unless disease free for ≥ 2 years
- Diagnosis of head and neck squamous cell carcinoma (SCC) in the oropharynx,
nasopharynx, hypopharynx, and larynx
- Unable or unwilling to complete NDII (baseline only)
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields
- Patient with severe, active co-morbidity that would preclude an elective or completion
neck dissection
- Pregnancy and breast-feeding mothers
- Incomplete resection of oral cavity lesion with a positive margin; however, an
excisional biopsy is permitted
- Prior surgery involving the lateral neck, including neck dissection or gross injury to
the neck that would preclude surgical dissection for this trial. Prior thyroid and
central neck surgery is permissible; biopsy is permitted. Note: Borderline suspicious
nodes that are ≥ 1 cm with radiographic finding suggestive of NOT malignant should be
biopsied using ultrasound-guided (U/S-guided) fine-needle aspiration (FNA) biopsy
- Underlying or documented history of hematologic malignancy (e.g., chronic lymphocytic
leukemia [CLL]) or other active disease capable of causing lymphadenopathy
(sarcoidosis or untreated mycobacterial infection)
- Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte
or immunomodulatory therapy
- Currently participating in another investigational therapeutic trial