Actively Recruiting
Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for Oral Cavity Squamous Cell Carcinoma PRECEDENT Trial
Led by University of Michigan Rogel Cancer Center · Updated on 2025-08-13
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating personalized neck radiation therapy guided by sentinel lymph node biopsy (SLNB) in patients with oral cavity squamous cell carcinoma (OCSCC). This phase II trial aims to determine whether using SLNB results to direct radiation therapy only to the affected side of the neck can reduce unnecessary radiation exposure to the opposite side. Standard treatment typically involves radiation to both sides of the neck, but this study explores whether radiation can be limited without increasing cancer recurrence, potentially improving outcomes related to saliva production, speech, swallowing, and reducing risks of radiation-induced complications. Participants will undergo SLNB, where a radiotracer is injected around the tumor to identify sentinel lymph nodes (SLNs). The biopsy results help decide if radiation therapy should target both sides or just the side with the primary tumor. Treatments include radiation therapy using high-energy x-rays or radioactive seeds, possibly combined with chemotherapy drugs like carboplatin, cisplatin, and paclitaxel. Additional procedures such as CT scans, PET-CT, SPECT-CT, video fluoroscopic swallow studies, and blood sample collections support treatment planning and monitoring. During the study, participants will be assessed for cancer control in the neck region one year after treatment, along with changes in neck function, oral dryness, and overall quality of life. Researchers will monitor recurrence-free survival, overall survival, and disease-specific survival up to one year post-treatment. Questionnaires and imaging studies will be used to evaluate outcomes, and participants will provide informed consent prior to enrollment. The study duration extends through at least one year of follow-up after definitive treatment to assess safety and effectiveness.
CONDITIONS
Brief Title
Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-proven squamous cell carcinoma of the oral cavity
- Clinical stage cT1-4a N0-2b M0 within 42 days of enrollment
- History and physical exam including documentation of lateralized primary tumor within 42 days
- Cross-sectional imaging of head, neck, and chest within 42 days
- ECOG Performance Status 0-2 within 42 days
- Age over 18 years
- Recommended for surgical resection with ipsilateral neck dissection and SPECT-CT-guided sentinel node biopsy
- Willing and able to provide informed consent
- Women of childbearing potential and males agree to use birth control during treatment phase
You will not qualify if you...
- Evidence of distant metastatic disease
- Evidence of contralateral neck disease on imaging
- Prior non-head and neck invasive malignancy unless disease free for 2 or more years
- Head and neck squamous cell carcinoma outside oral cavity (oropharynx, nasopharynx, hypopharynx, larynx)
- Prior systemic chemotherapy for this cancer
- Prior radiotherapy overlapping study cancer region
- Severe active co-morbidity preventing neck dissection
- Pregnant or breastfeeding
- Excisional biopsy for study cancer
- Prior surgery involving lateral neck or gross neck injury precluding dissection
- History of hematologic malignancy or other diseases causing lymphadenopathy
- Current systemic cytotoxic chemotherapy, immunosuppressive, or immunomodulatory therapy
- Currently in another investigational therapeutic trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several weeks depending on treatment schedule
Participants undergo sentinel lymph node mapping and biopsy followed by personalized neck radiation therapy and chemotherapy.
Multiple visits including procedures, radiation therapy sessions, and chemotherapy infusions
Duration - Up to 1 year after treatment completion
Participants are monitored up to 1 year after completing treatment to assess neck function, oral dryness, quality of life, and survival outcomes.
Periodic visits for assessments and questionnaires
Trial Site Locations
Total: 1 location
1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
Cancer AnswerLine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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