Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatme
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
| Condition(s) | Oral Cavity Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Cancer AJCC v8, Stage II Lip and Oral Cavity Cancer AJCC v8, Stage III Lip and Oral Cavity Cancer AJCC v8, Stage IVA Lip and Oral Cavit |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | 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 inf |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Michigan Rogel Cancer Center |
| Locations | Ann Arbor, Michigan, United States |
| Start date | 2025-07-17 |
| NCT ID | NCT07121595 |
| Official listing | https://clinicaltrials.gov/study/NCT07121595 |