Randomized Phase II/III Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer

Cancer Categories

Head and Neck

Karmanos Trial ID

NRG-HN006

NCT ID

NCT04333537

Age Group

Adult

Scope

National

Phase

Phase II/III

Principal Investigator

John
Cramer, M.D.
Ear Nose & Throat (Otolaryngology), Oncology - Surgical View Profile

Objective:

Primary Objectives Phase II:

To determine if patient-reported neck and shoulder function and related quality of life (QOL) at 6 months after surgery using the Neck Dissection Impairment Index (NDII) is superior with Sentinel Lymph Node (SLN) biopsy compared to Elective Neck Dissection (END) for treatment of early-stage oral cavity squamous cell carcinoma (OCSCC) (cT1-2N0).

Primary Objectives Phase III:

To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0).
To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using NDII is superior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0).

Secondary Objectives:

To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms.
To measure and compare overall survival (OS) between surgical arms.
To measure and compare the toxicity of the two surgical arms.
To measure longitudinal patient-reported neck and shoulder function and related QOL between surgical arms, using the following instruments:

Neck Dissection Impairment Index (NDII)
Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N)

To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms.
To estimate the negative predictive rate of FDG PET/CT for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm.
To assess nodal metastases rates between arms.
To assess the pathologic false omission rate (FOR) in the SLN biopsy arm.
To determine if patient-reported neck and shoulder function and related QOL at 6 months after surgery using the NDII is superior with the SLN biopsy compared to the END in low-risk patients.

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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

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

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