Oral cavity cancer
Conditions
Interventions
Sentinel lymph node biopsy
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. The patient has provided written informed consent authorization before participating in the study. 2. The patient has a diagnosis of primary lateralized oral squamous cell carcinoma, that does not involve the midline and is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone), floor-of-the-mouth, hard palate or oral (mobile) tongue. 3. Clinical nodal staging of the positive ipsilateral neck (N1-N3) has been confirmed by ul-trasound, MRI and/or fine needle aspiration cytology within 30 days of the SLN procedure. 4. Clinical nodal staging of the negative contralateral neck (N0) has been confirmed by neg-ative results from ultrasound, MRI and/or fine needle aspiration cytology within 30 days of the SLN procedure. 5. The patient is a candidate for surgical tumor resection and ipsilateral neck dissection. 6. Patients with prior malignancy in the head and neck area are allowed, provided the patient meets both of the following criteria: • Underwent potentially curative therapy for all prior head and neck malignancies and is deemed low risk for recurrence; and • No head and neck malignancy for the past five years (except effectively treated basal cell or squamous cell skin cancer) and no evidence of recurrence. 7. The patient is =18 years of age at the time of consent. 8. The patient has an ECOG status of Grade 0-2 (Appendix 4: Performance Status Criteria).
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. The patient has a diagnosis of squamous cell carcinoma of the head and neck in the fol-lowing anatomical areas: non-mobile base of the tongue, oropharynx, nasopharynx, hy-popharynx, and larynx. 2. The patient is incapacitated. 3. The patient has had a previous allergic reaction after administration of a radionuclide tracer. 4. The patient has had other nuclear imaging studies, conducted within 10 days (240 hours) of injection. 5. The patient has a history of neck dissection, or gross injury to the neck that would pre-clude reasonable surgical dissection for this trial, or radiotherapy to the neck. 6. The patient is actively receiving systemic cytotoxic chemotherapy. 7. The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this prospective study is the rate of occult contralateral lymph node metastases in patients with lateralized oral cavity squamouss cell carcinoma, a clinically negative contralateral neck and a clinically ipsilateral positive neck. | — |
Secondary
| Measure | Time frame |
|---|---|
| • The incidence of contralateral drainage patterns, as assessed by means of 99mTc-nanocolloid lymphoscintigraphy, in patients with lateralized oral cavity squamous cell carcinoma, a clinically negative contralateral neck and clinical ipsilateral lymph node metastases. • The incidence and degree of postoperative complications, graded by means of the Clavien-Dindo classification of Surgical Complications, in patients who underwent additional sentinel lymph node biopsy and patients who did not undergo additional sentinel lymph node biopsy and only underwent surgical tumor resection and ipsilateral neck dissection. • The duration of hospital stay in days in patients who underwent additional SLNB and patients who did not undergo additional sentinel lymph node biopsy and only underwent surgical tumor resection and ipsilateral neck dissection • Tumor specific data (i.e. clinical TNM-staging, size and site of the primary tumor, distance from the midline of the primary tumor, depth-of-invasion of the primary tumor, histopathological grading of the primary tumor, perineural and lymphovascular invasion of the primary tumor, amount of ipsilateral cervical lymph nodes containing metastases, location of cervical lymph nodes containing metastases and presence of extranodal growth of lymph node metastases) will be obtained from electronical health records. | — |
Contacts
Public ContactRutger Mahieu
University Medical Center Utrecht
Outcome results
None listed