NCT07121595RecruitingPhase 2
Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial
PRECEDENT: Pilot Phase II Study of Personalized Radiation to the Contralateral Neck Directed by Sentinel Node Evaluation in Lateralized Oral Cavity Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 6 Aug 2025
- Start date
- 17 Jul 2025
- Primary completion date
- 1 Jul 2030
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT07121595
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 17 Jul 2025 to the primary completion date, 1 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed. Prior immunotherapy for the study cancer is allowed.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- 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; incisional biopsy is permitted
- Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy
Other illness
- Evidence of distant metastatic disease based on clinical or radiologic evaluation
- Evidence of contralateral neck disease on staging imaging
- Excisional biopsy for study cancer
- 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)
Other
- Diagnosis of head and neck squamous cell carcinoma (SCC) in the oropharynx, nasopharynx, hypopharynx, and larynx
- Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection
- Pregnant and breast-feeding patients
- Currently participating in another investigational therapeutic trial
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Michigan Comprehensive Cancer Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.