Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sentinel Lymph Node (SLN) Biopsy
Patients receive an imaging agent via injection and undergo planar imaging and SPECT/CT over 1-2 hours. Patients then undergo SLN biopsy.
  • Procedure: Computed Tomography (CT)
    Undergo SPECT/CT scan
    Other names:
    • CAT
    • CAT scan
    • Computed Tomography
    • computerized axial tomography
    • Computerized Tomography
    • CT
    • CT scan
    • tomography
  • Drug: Imaging Agent
    Receive imaging agent via injection
    Other names:
    • Image Enhancement Agent
  • Procedure: Planar Imaging
    Undergo planar imaging
  • Procedure: Sentinel Lymph Node Biopsy
    Undergo SLN biopsy
    Other names:
    • Sentinel Node Biopsy
    • Sentinel node biopsy alone
    • SLNB
    • SNB
  • Procedure: Single Photon Emission Computed Tomography
    Undergo SPECT/CT scan
    Other names:
    • Medical Imaging, Single Photon Emission Computed Tomography
    • Single Photon Emission Tomography
    • single-photon emission computed tomography
    • SPECT
    • SPECT imaging
    • SPECT SCAN
    • SPET
    • tomography, emission computed, single photon
    • Tomography, Emission-Computed, Single-Photon
Active Comparator
Elective Neck Dissection (END)
Patients undergo standard END.
  • Procedure: Computed Tomography (CT)
    Undergo SPECT/CT scan
    Other names:
    • CAT
    • CAT scan
    • Computed Tomography
    • computerized axial tomography
    • Computerized Tomography
    • CT
    • CT scan
    • tomography
  • Procedure: Neck Dissection
    Undergo standard elective neck dissection

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Site Public Contact
617-638-8265

More Details

Status
Recruiting
Sponsor
NRG Oncology

Study Contact

Detailed Description

PRIMARY OBJECTIVES: I. 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). (Phase II) II. To determine if disease-free survival (DFS) is non-inferior with SLN biopsy compared to END for treatment of early-stage OCSCC (cT1-2N0). (Phase III) III. 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). (Phase III) SECONDARY OBJECTIVES: I. To compare patterns of failure (local-regional relapse and distant metastasis) between surgical arms. II. To measure and compare overall survival (OS) between surgical arms. III. To measure and compare the toxicity of the two surgical arms. IV. To measure longitudinal patient-reported neck and shoulder function and related QOL between surgical arms, using the following instruments: IVa. Neck Dissection Impairment Index (NDII). IVb. Abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH). IVc. Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N). V. To assess the length of hospitalization, post-operative drain placement, and operative morbidity between arms. VI. To estimate the negative predictive rate of fludeoxyglucose F-18 (FDG)-positron emission tomography/computed tomography (PET/CT) for N0 neck in patients with T1 and T1-2 oral cavity squamous cell cancer (OCSCC) patients in the END arm. VII. To assess nodal metastases rates between arms. VIII. To assess the pathologic false omission rate (FOR) in the SLN biopsy arm. IX. 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. EXPLORATORY OBJECTIVES: I. To compare changes in patient-reported outcomes (European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between surgical arms. II. To collect biospecimens for future translational science studies. III. To assess the DFS between arms in low-risk patients. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive an imaging agent via injection and undergo planar imaging and single photo emission computed tomography/computed tomography (SPECT/CT) over 1-2 hours. Patients then undergo SLN biopsy. GROUP II: Patients undergo standard END. After completion of study treatment, patients are followed up 3 weeks after surgery, every 3 months for year 1, every 4 months for year 2, every 6 months for year 3, then yearly thereafter.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.