Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of O… (NCT07121595) | Clinical Trial Compass
RecruitingPhase 2
Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial
United States50 participantsStarted 2025-07-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 throughout their participation in the treatment phase of the study
Exclusion Criteria:
* Evidence of distant metastatic disease based on clinical or radiologic evaluation
* Evidence of contralateral neck disease on staging imaging
* 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 n…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Contralateral regional control rate
Timeframe: From completion of definitive treatment to neck recurrence date, death date or date of last contact, assessed at 1 year from completion of definitive treatment