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Personalized Neck Radiation for Oral Cavity Squamous Cell Carcinoma

This study is looking at a new way to plan radiation therapy for oral cavity squamous cell carcinoma (a type of mouth cancer). It uses a procedure called sentinel lymph node biopsy (SLNB) to help doctors decide if radiation is needed on one or both sides of your neck. Currently, radiation is given to both sides regardless of SLNB results. This trial aims to see if using SLNB to personalize radiation treatment (using Carboplatin or Cisplatin) can still effectively control cancer in the neck. You may be eligible if you have biopsy-proven oral cavity squamous cell carcinoma, stages I to IVA, and are at least 18 years old. The main goal is to see how well the cancer is controlled in the neck after one year.

Study design
This is a Phase II interventional study planning to enroll 50 participants. It is designed to test a personalized approach to radiation therapy.
What's involved
You would undergo biospecimen collection (blood samples), CT scans, and a modified barium swallow test. You would also receive Carboplatin or Cisplatin intravenously.
Compensation
Not stated in the trial record.
Follow-up
Your regional control rate will be assessed for up to one year after completing treatment.

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NCT07121595

Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Michigan Rogel Cancer Center
~50 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCarboplatinCisplatinComputed TomographyModified Barium SwallowPaclitaxel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Contralateral regional control rate
Measured over 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

Conditions

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 Cavity Cancer AJCC v8

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Oral Cavity Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Jennifer L Shah · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center

Who to contact

Cancer AnswerLine
[email protected]
1-800-865-1125
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 neck squamous cell carcinoma (SCC) in the oropharynx, nasopharynx, hypopharynx, and larynx
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
Patient with severe, active co-morbidity that would preclude an elective or completion neck dissection
Pregnant and breast-feeding patients
Excisional biopsy for study cancer
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
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)
Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy
Currently participating in another investigational therapeutic trial

What this trial measures

  • Contralateral regional control rateFrom completion of definitive treatment to neck recurrence date, death date or date of last contact, assessed at 1 year from completion of definitive treatment

    Contralateral regional control rate is defined as the proportion of evaluable subjects free of contralateral neck recurrence at 1 year from completion of definitive treatment. Regional Recurrence is defined as biopsy-proven cancer within the ipsilateral or contralateral neck at any time point after initial surgical resection. When biopsy is not feasible, evidence of recurrence by imaging suffices only with documented attestation at tumor board that the imaging is clinically diagnostic of regional recurrence. Cumulative incidence function estimate with 90% confidence interval (CI) for follow-up after 1 year.