Comparing an Alternative Surgical Procedure, Sentinel Lymph Node (SLN) Biopsy, with Standard Neck Dissection for Patients with Early-Stage Oral Cavity Cancer
Comparing an Alternative Surgical Procedure, Sentinel Lymph Node (SLN) Biopsy, with Standard Neck Dissection for Patients with Early-Stage Oral Cavity Cancer
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.
Head/Neck
Phase II/III
Adults
Not Available
Not Available
Topf, Michael
International
Vanderbilt University
05-03-2021
Eligibility
18 Years
BOTH
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
Age >= 18
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 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 (U/S)-guided fine-needle aspiration (FNA) biopsy
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
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
Age >= 18
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 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 (U/S)-guided fine-needle aspiration (FNA) biopsy
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
