Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
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
- 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
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
| Arm | Description | Assigned 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. |
|
|
Active Comparator Elective Neck Dissection (END) |
Patients undergo standard END. |
|
Recruiting Locations
Tucson, Arizona 85719
Tucson, Arizona 85719
Little Rock, Arkansas 72205
Site Public Contact
501-686-8274
Duarte, California 91010
La Jolla, California 92093
Palo Alto, California 94304
San Jose, California 95124
New Haven, Connecticut 06520
Trumbull, Connecticut 06611
Coral Gables, Florida 33146
Site Public Contact
305-243-2647
Deerfield Beach, Florida 33442
Site Public Contact
305-243-2647
Miami, Florida 33136
Site Public Contact
305-243-2647
Atlanta, Georgia 30308
Site Public Contact
888-946-7447
Atlanta, Georgia 30322
Site Public Contact
404-778-1868
Chicago, Illinois 60611
Chicago, Illinois 60612
Iowa City, Iowa 52242
Site Public Contact
800-237-1225
Kansas City, Kansas 66160
Westwood, Kansas 66205
Shreveport, Louisiana 71103
Ann Arbor, Michigan 48109
Site Public Contact
800-865-1125
Detroit, Michigan 48201
Detroit, Michigan 48202
Farmington Hills, Michigan 48334
Omaha, Nebraska 68114
Site Public Contact
402-334-4773
Omaha, Nebraska 68114
Site Public Contact
402-354-5144
Omaha, Nebraska 68114
Basking Ridge, New Jersey 07920
Site Public Contact
212-639-7592
Livingston, New Jersey 07039
Middletown, New Jersey 07748
Site Public Contact
212-639-7592
Montvale, New Jersey 07645
Site Public Contact
212-639-7592
New Brunswick, New Jersey 08903
Site Public Contact
732-235-7356
Buffalo, New York 14263
Commack, New York 11725
Site Public Contact
212-639-7592
Harrison, New York 10604
Site Public Contact
212-639-7592
Mineola, New York 11501
New York, New York 10016
New York, New York 10065
Site Public Contact
212-639-7592
Uniondale, New York 11553
Site Public Contact
212-639-7592
Cleveland, Ohio 44195
Columbus, Ohio 43210
Oklahoma City, Oklahoma 73104
Clackamas, Oregon 97015
Portland, Oregon 97213
Portland, Oregon 97225
Danville, Pennsylvania 17822
Philadelphia, Pennsylvania 19107
Pittsburgh, Pennsylvania 15232
Site Public Contact
412-647-8073
Pittsburgh, Pennsylvania 15232
Site Public Contact
412-621-2334
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57105
Sioux Falls, South Dakota 57117-5134
Memphis, Tennessee 38104
Site Public Contact
901-516-2579
Memphis, Tennessee 38163
Nashville, Tennessee 37232
Site Public Contact
800-811-8480
Conroe, Texas 77384
Houston, Texas 77030
Houston, Texas 77030
Houston, Texas 77030
Site Public Contact
800-553-2278
Houston, Texas 77079
League City, Texas 77573
Sugar Land, Texas 77478
Berlin, Vermont 05602
Site Public Contact
802-225-5400
Burlington, Vermont 05401
Burlington, Vermont 05405
More Details
- NCT ID
- NCT04333537
- Status
- Recruiting
- Sponsor
- NRG Oncology
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.