Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer.
Primary Endpoint:
Phase II: Patient-reported neck and shoulder function and related QOL, as measured by NDII.
Phase III: Disease-Free Survival (DFS) (Failure: local/regional recurrence, distant metastasis, or death due to any cause). Patient-reported neck and shoulder function and related QOL, as measured by NDII.
Secondary Endpoints:
1. Overall Survival (OS)
2. Locoregional failure and distant metastasis
3. Toxicity, as measured by the CTCAE v5.0
4. Patient-reported shoulder-related QOL, function impairment and disability using QuickDASH, and patient-reported general QOL using the FACT-H&N
5. Nodal metastasis detection rate
6. Pathologic false omission rate (FOR) in the SLN biopsy arm
7. Length of hospitalization, post-operative drain placement, and operative morbidity
8. NDII for low-risk patients
- Rutgers Cancer Institute of New Jersey
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.