Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial
This study tests a new approach to treating oral cavity cancer by using a sentinel lymph node biopsy to identify which patients need neck radiation therapy. Instead of giving radiation to all patients, this personalized approach aims to give radiation only to those patients who need it based on their lymph node status.
Key Objective: The potential benefit is reducing unnecessary radiation therapy to the neck while still effectively treating patients with oral cavity squamous cell carcinoma.
Who to Consider: Patients with oral cavity squamous cell carcinoma who are candidates for sentinel lymph node biopsy and may need neck treatment should consider enrolling in this trial.
Trial Parameters
Brief Summary
This phase II trial studies how well personalized neck radiation therapy directed by sentinel lymph node biopsy (SLNB) works in treating patients with oral cavity squamous cell carcinoma (OCSCC). SLNB can be performed as part of standard care for OCSCC. During SLNB, a radiotracer is injected around the tumor. The lymph nodes are then biopsied and tested to see if the tracer injected into the tumor traveled to and is present in the sentinel lymph nodes (SLNs). Results of the SLNB are used to determine whether lymph nodes should be removed in both sides of the neck or just on the same side as the primary tumor. Standard treatment then involves radiation therapy to both sides of the neck, regardless of SLNB results. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Studies have shown only a small number of patients develop a return of the cancer (recurrence) in the opposite side of the neck after radiation therapy. In addition, radiation therapy can negatively impact patient outcomes like saliva production, speech and swallow function, increased risk of radiation induced cancers, and chronic pain. Standard of care SLNBs may be effective in determining whether radiation therapy only needs to be administered to one side of the neck or both sides. This may help spare tissue on the opposite side of the neck from receiving radiation if there is no indication of lymph node involvement there.
Eligibility Criteria
Inclusion Criteria: * Patient must have biopsy-proven squamous cell carcinoma of the oral cavity * Clinical stage cT1-4a N0-2b M0 within 42 days of study enrollment based on the following work-up: * History and physical examination within 42 days of study enrollment; must include documentation of lateralized primary tumor site * Cross-sectional imaging of the head and neck within 42 days of study enrollment * Cross-sectional imaging of the chest within 42 days of study enrollment * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 within 42 days of study enrollment * Age \> 18 * Recommended treatment plan is surgical resection with ipsilateral neck dissection and SPECT-CT-guided sentinel node biopsy. Flap reconstruction is allowed * Patient is willing and able to provide informed consent. Patient provides study-specific informed consent prior to study entry * Women of childbearing potential and male participants must agree to use medically effect means of birth control t